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February 19, 2014

Leerink's Global Healthcare Conference 2014 Focuses on a Variety of Emerging Health Products

leerink.pngOn February 12 and 13, 2014, Leerink Partners LLC ("Leerink") held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference includes emerging themes in healthcare, where Leerink's equity analysts moderate discussions with MEDACorp specialists to provide unique and timely insights.

In addition to the company presentations, this year's line up featured the following panels or keynote speakers with some observed comments or trends:

• Panel: The Future of Medical Devices in an Evolving Landscape: A Shifting Emphasis to Patient Monitoring and Customizable Solutions

  • Patients view surgeons that incorporate robotics in their practice as the better doctors, driving more surgeons to utilize them in their practice. As surgeons become more familiar with these devices, patients may have more options for surgical procedures and implants.

  • Larger companies are looking at controlling infections caused by implanted medical devices with special coatings--either anti-infectives or antibiotics, particularly for use in higher-risk patients. There is an increasing need, however, for implants to have built-in tools for monitoring the devices. But as medical devices become more complex, such as hip, knee, or total joint replacements, these devices will require preapproval marketing applications ("PMAs") with clinical data rather than less costly and time-consuming 510(k)-type premarket clearance applications. Since PMAs cost companies more than 510(k) applications, these newer devices will cost third party payors and patients more.

  • Hospitals continue to be under a lot of pressure not to lose patients, so they may seek lower margins by having surgeons add anti-infective coatings or antibiotics rather than purchasing more costly versions with the coatings or by importing "generic" implants from other countries that may not be as rugged as the versions cleared for use in the U.S. FDA's new unique device identifiers and improved monitoring, however, may reduce use of such imported devices with unclear pedigrees.

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December 4, 2013

23andMe Suspends Access to Health-Related Information

23andme.jpg23andMe, the Google-backed direct-to-consumer genetic testing provider, has suspended its health-related genetic testing in response to FDA's November 22, 2013 Warning Letter. In the Warning Letter, FDA directed 23andMe to "immediately discontinue marketing [its Saliva Collection Kit and Personal Genome Service, "PGS"] until such time as it receives FDA marketing authorization for the device." While 23andMe will discontinue access to health-related services, 23andMe will continue to provide access to raw genomic data as well as ancestry-related applications. Also, customers who purchased 23andMe prior to FDA's Warning Letter will still have access to health-related results.

The Warning Letter deemed the PGS a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act"). 21 U.S.C. 321(h). Section 201(h) defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" or is "intended to affect the structure or any function of the body." FDA determined that the PGS fell within this definition, because it was marketed as providing, "health reports on 254 diseases and conditions." In particular, 23andMe was marketed as a "first step in prevention" for diseases like diabetes, coronary heart disease, and breast cancer.

FDA is particularly concerned about the "potential health consequences that could result from false positive or false negative assessments for high-risk indications." For example, a false positive BRCA-related risk assessment [A BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2. Harmful mutations in these genes produce a hereditary breast-ovarian cancer syndrome in affected families.] Mutations in BRCA1 and BRCA2 are uncommon, and breast cancer is relatively common, so these mutations consequently account for only five to ten percent of all breast cancer cases in women.[may lead to unnecessary prophylactic surgery or chemoprevention. On the other hand, a false negative may lead to a failure to appreciate actual risk. FDA was also concerned about drug response assessments, such as warfarin sensitivity or clopidogrel response. For example, a false positive BRCA-related risk assessment [a BRCA mutation is a mutation in either of the genes BRCA1 and BRCA2 that is associated with a hereditary breast-ovarian cancer syndrome in affected families] may lead to unnecessary prophylactic surgery or chemoprevention.

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September 26, 2013

Smartphone Health App Guidance Issued by FDA

medical app.pngOn September 25, 2013, FDA issued a final Guidance for Industry and Food and Drug Administration Staff entitled, "Mobile Medical Applications". This Guidance discusses FDA's intention to oversee the use of mobile applications ("apps") that qualify as medical devices and that pose a risk to the user if they do not function as intended. These "mobile medical apps" meet the definition of a medical device, and are either intended "to be used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device." Section 201(h) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") defines a device as

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . [I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or . . . [I]ntended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDA places mobile medical apps in the same category of risk as currently regulated devices and intends to regulate them in the same way. The Guidance aims to assist manufacturers in determining whether a product qualifies as a mobile medical app and, if so, provides FDA's regulatory requirements. FDA sets forth three types of mobile medical apps that it intends to apply regulatory oversight to:


  1. Mobile apps that connect to medical devices and are extensions of these devices that control, display, store, analyze, or transmit data from the medical device.

    For example: an app that controls the delivery of insulin by transmitting signals to an insulin pump.


  2. Mobile apps that transform the mobile platform into a regulated medical device.

  3. For example: an app that attaches electrocardiogram electrodes to a mobile platform to measure, store, and display electrocardiogram signals.

  4. Mobile apps (software) that perform patient-specific analyses and then provide patient-specific diagnoses or treatment recommendations.

  5. For example: an app that calculates radiation dosages or creates dosage plans for radiation therapy

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July 31, 2013

FLH's Brian Malkin Quoted in Unique Device Identifier Rule Article in Medpage Today

UDIdevice.bmpFDA continues to be late in issuing its final rules to implement the unique device identifier ("UDI") system authorized in 2007. Congress had requested that FDA finalize the rule by June 19, 2013, but FDA's latest action has been its proposed rules published in the Federal Register on July 10, 2012.

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help FDA identify product problems more quickly, better target recalls and improve patient safety.

FDA is also reportedly creating a database that will include a standard set of basic identifying elements for each UDI, which it plans to make generally available to the public so that medical device users can easily find more information about specific devices. The UDI does not indicate and FDA's database will not contain any information about who uses a device, including any personal privacy information.

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July 25, 2013

ADHD-Diagnosing Device NEBA Approved--First of its Kind

ADHDBrainWaveDevice.jpgOn July 15, FDA announced its approval of the first brain- function-based medical device to help diagnose attention deficit hyperactivity disorder ("ADHD") in children and adolescents. The approved device, the Neuropsychiatric Electroencephalogram-Based Assessment Aid ("NEBA") System, uses an electroencephalogram ("EEG") to measure brain waves with sensors attached to a child's head, which are wired to a computer. After fifteen to twenty minutes of information-gathering, it provides a read-out of the types and timing of electrical impulses, i.e., waves, emitted by brain nerve cells. Because two kinds of brain waives--theta and beta--may be more common in ADHD children, physicians can use this information to confirm an ADHD diagnosis or direct further diagnostic testing.

EEG technology has been around since the early 1900s and is often used to diagnose sleep disorders, measure unconsciousness, evaluate the brain post-head trauma, and monitor the brain during surgery. ADHD, which results in attention difficulties, hyperactivity, impulsivity and behavioral problems, is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of U.S. adolescents have ADHD and the average age of diagnosis is seven years. "Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," explained Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health ("CDRH")

The manufacturer of the NEBA System, NEBA Health of Augusta, Georgia, provided FDA with data including a clinical study that evaluated 275 children and adolescents (ages 6 to 17 years) with attention/behavioral issues, using both the approved device and standard diagnostic testing such as questionnaires and physical exams. An independent group of ADHD experts also reviewed the data and reached a consensus as to whether each subject had ADHD. According to FDA, the side-by-side results "showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."

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March 14, 2013

FLH Partner Brian Malkin Attends MassBio's Annual Meeting

FLH Partner Brian J. Malkin will attend the Massachusett's Biotechnology Council's ("MassBio's") Annual Meeting in Cambridge, Massachusetts on March 14-15, 2013. FLH is a member of MassBio, reflecting FLH's commitment to the development and promotion of new biological and related products. Each year, the MassBio Annual Meeting focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. The meeting program is pulled together by a Steering Committee of leaders in the industry and the agenda encompasses keynote presentations, panel discussions, interactive working sessions, and extensive networking opportunities for all MassBio members. This year, keynote presentations feature John Crowley, Chairman & CEO of Amicus Therapeutics, Inc. and FDA Commissioner Margaret A. Hamburg, M.D. Key topics of interest include personalized medicine and companion diagnostics, biosimilars, RNA therapeutics, healthcare reimbursement strategies, research resource sharing opportunities and a variety of orphan drug candidate topics. Mr. Malkin looks forward to seeing you and catching up on the latest biotechnology developments with some of the best biotechnology leaders in the Massachusetts area and beyond.

March 13, 2013

Public Citizen Asks FDA to Withdraw Approval of Stryker's Wingspan Stent--Again

On January 28, 2013, consumer-advocacy group Public Citizen filed a letter "in response" for FDA to reconsider its August 8, 2012 denial of the group's petition that asked FDA to withdraw its approval for a medical device directed to stent technology. Public Citizen's original petition urged the withdrawal of approval for and recall of Stryker Corporation's ("Stryker's") Wingspan Stent System with Gateway PTA Balloon Catheter ("Wingspan Stent"), which is used to treat narrowing of the blood vessels in the brain.



In its January 28 letter, Public Citizen claimed that FDA denied the petition based on flawed reasoning. Specifically, Public Citizen argued that FDA's decision minimized the importance of crucial scientific evidence indicating that the Wingspan Stent is ineffective and, furthermore, that it is more harmful to patients experiencing intracranial narrowing of the blood vessels when compared to alternative forms of treatment. Public Citizen also criticized FDA's attempt at comprise by narrowing the proposed indication of the stent in response to the scientific data outlined in the petition. Public Citizen argued that such attempts fell far short of being sufficient to ensure the safety of patients that might consider using Stryker's medical device.

The Wingspan Stent is a class III medical device that comprises a stent with a balloon catheter and, until recently, was indicated for use "in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis [(a narrowing of the blood vessels that supply blood to the brain)] that are accessible to the system." In simple terms, the device uses a self-expanding tube that is inserted into a blocked artery in the brain with the "goal of increasing blood flow and preventing strokes in patients who have experienced repeat strokes, even after taking medication to prevent blood clotting."

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March 6, 2013

Medical Device Communication Draft Guidance Issued

communicate.jpgOn March 5, FDA issued a new draft guidance, "Types of Communication During the Review of Medical Device Submissions." During the development of the various medical device user fee amendments ("MDUFA"), the discussion of improving communications between device applicants and FDA was suggested, described as an Interactive Review. The collection of additional funds from MDUFA-related activities will enable FDA to improve the device review process and help meet certain performance goals incorporated into MDUFA. Some of the suggested communications included Acceptance Review, Substantive Interactions, Interactive Review, and, where applicable, Missed MDUFA Goals.

The purpose of Acceptance Review communications are to: (1) identify the lead reviewer or Regulatory Project Manager assigned to the submission and (2) confirm acceptance of the submission or notify the submitter that the submission was not accepted based upon the review of objective acceptance criteria. FDA aims to make these communications within 15 days of receipt of a 510(k), original premarket approval application ("PMA"), or a Panel-Track PMA Supplement, with such confirmation by fax, e-mail, or other written communication.

Substantive Interactions tell applicants that FDA either: (1) intends to continue working with the applicant to resolve any outstanding deficiencies (no hold), or (2) FDA has identified deficiencies sufficient to place the submission on hold. Substantive Interactions should occur following acceptance of the submission and only after FDA has performed a complete review with targets of within 60 days of receipt of a complete 510(k) or within 90 days of the filing date of an original PMA, Panel-Track PMA Supplement, or 180-Day PMA Supplement.

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February 18, 2013

Seyfert-Margolis Headlines Leerink Swann's Global Healthcare Conference in New York

pills.jpgOn February 13 and 14, 2013, Leerink Swann ("Leerink") held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference highlights emerging themes and controversies in healthcare, where Leerink's equity analysts present surveys and moderate discussions with MEDACorp Key Opinion Leaders and industry specialists to provide unique and timely insights. MEDACorp is Leerink's network of 30,000 healthcare professionals including key opinion leaders, practitioners, clinicians, and hospital administrators. In between the main panels, senior management from some of the companies identified by Leerink as the most prominent and promising deliver "fireside chats" and presentations with company updates, including discussions of new products in their pipeline under review. This year the sole sponsor of Leerink's Global Healthcare Conference was Latham & Watkins LLP.

Headlining the Conference was a Keynote Address entitled "Innovating Medical Product Development - FDA and Other Forward Looking Trends" delivered by Vicki L. Seyfert-Margolis, Ph.D. Seyfert-Margolis just recently was the Senior Advisor for Science Innovation and Policy in FDA's Office of the Commissioner. Seyfert-Margolis is currently Chief Science and Strategy Officer for Precision Health, which provides services, infrastructure, and technologies to companies developing personalized medicines.

Seyfert-Margolis worked for about three and a half years in FDA's Office of the Commissioner, where she led the effort to help develop a more coherent policy for companion diagnostic and personalized medicine, including developing guidances for personalized medicine such as "In Vitro Companion Diagnostic Devices" and "Qualification Process for
Drug Development Tools
". While at FDA, Seyfert-Margolis looked at why companies were not seeing as many returns from their investments in research and development, noting that it was not FDA's "fault" for less new chemical entity filings, because FDA can only review or approve products that are filed in new applications.

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January 23, 2013

Combination Product Final Rule and Guidance Issued to Streamline CGMP and Supplements

Thumbnail image for 3699948229_d7732f8df0_o.jpgYesterday, FDA issued two new items to help clarify combination products: 1) a Final Rule published in the Federal Register entitled, "Current Good Manufacturing Practice Requirements for Combination Products" and 2) a Draft Guidance entitled, "Guidance for Industry and FDA Staff:
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA", also announced in the Federal Register.

The Final Rule is intended to clarify which good manufacturing practice ("CGMP") requirements apply when drugs, devices, and biological products are combined to create combination products. The Rule also provides a mechanism that FDA describes as "transparent and streamlined regulatory framework" for companies to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products. "Single-entity" combination products are two or more regulated components, e.g., drug/device, biologic/device, drug/biologic/device, which are physically, chemically, or otherwise combined or mixed and produced as a single-entity. Two or more separate products packaged together in a single package or as a unit and comprised of two or more regulated products is a "co-packaged" combination product. The Final Rules started as a Draft Guidance announced on October 4, 2004 (69 FR 59239), entitled "Current Good Manufacturing Practices for Combination Products." Based on comments and FDA's own internal review, FDA decided that "rulemaking was warranted" and issued Proposed Rules on September 23, 2009 (74 FR 48423).

The concept behind the CGMP Rule is simple for parts that are separately manufactured and marketed: each of the constituent parts of a combination product are subject only to the CGMP regulations applicable to that part, e.g., drug, biologic, or device. The two categories of combination products mentioned above, however, "single-entity" and "co-packaged" are slightly different due to the possibility for overlapping CGMP requirements for the different regulated components. Companies have two basic options for these types of products: 1) demonstrate compliance with the specifics of all CGMPs to each of the parts, or 2) demonstrate compliance with the specifics of either the drug CGMPs at 21 C.F.R. Parts 210 and 211 or the quality system ("QS") regulation at 21 C.F.R. Part 820 rather than both, for drug/devices under certain conditions. For combination products including biologics, the specific regulations are 21 C.F.R. parts 600 through 680, and for product including any human cell, tissue, and cellular tissue-based products, the regulations are 21 C.F.R. Part 1271.

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January 22, 2013

Kozlowski, Joneckis, and Shuren Provide FDA Overview of Biotechnology Issues

Thumbnail image for DNA2.jpgToday, FDA Center Officials from the Center for Drug Evaluation and Research ("CDER"), the Center for Biologics Evaluation and Research ("CBER"), and the Center for Devices and Radiologic Health ("CDRH") provided an overview of upcoming biotechnology issues to the TechCouncil of Maryland, MdBio / MdTech at a full house in Bethesda, Maryland.

Representing CDER, Steven Kozlowski, M.D., Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, said that his Office, which regulates monoclonal antibodies and therapeutic proteins, has been primarily concerned with the mechanism of action and potential for immunogenicity for these products. Describing a triad of research and development, application review, and inspections, Kozlowksi described his Office's challenges as often concerning "too many notes" for biologics--discerning which notes matter, given that technology has come up with ways to further characterize products and reveal more notes.

Kozlowski said that through the life cycle continuum of a biotechnology product, it is the applicant's responsibility to make sure that biotechnology products are manufactured using the best available science to prevent issues such as viral contamination that can cause plant shut downs and shortages. To help prevent such issues, FDA is further integrating its review and compliance functions, in part with the use of new user fee authorizations. For biosimilars, FDA recognizes the studies necessary for approval will depend on the analytics and results from those analytics, comparing the innovator's product to the proposed biosimilar product.

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January 18, 2013

Safe Harbor Provision Case Not Selected for Supreme Court Review

Thumbnail image for Thumbnail image for supremecourt.pngEarlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

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September 21, 2012

Mammography Screening Device Approved for Dense Breasts

On September 18, FDA approved the first medical device approved for ultrasound imaging for use in standard mammography screenings for women with dense breast tissue. Sunnyvale, California-based U-Systems manufactures the device called the somo-v® Platinum Automated Breast Ultrasound System ("ABUS"). The decision follows a unanimous recommendation to approve the device by an advisory panel.

Dense breasts have a high amount of connective and glandular tissue compared to breasts that have a higher percentage of fatty tissue. Physicians can determine whether a woman has dense breast tissue via a mammography exam. The National Cancer Institute currently estimates that about 40 percent of the women having mammography screening have dense breasts. These women appear to have a higher risk for breast cancer as well.

Mammography is a low-dose x-ray image of the breast. Until the ABUS, mammograms of breasts with dense tissue show both fibroglandular breast tissue and tumors as solid white areas on a mammogram, making results difficult to interpret. Often the dense breast tissue would obscure smaller breast tumors, which could delay breast cancer detection.

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September 11, 2012

User Fee Sequestration Imminent as Congress and Obama Fails to Decide on Government-Wide Budget Cuts

Thumbnail image for Thumbnail image for Thumbnail image for FDA.jpegOn January 2, 2013, barely three months after FDA's new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from using the user fees it collects from industry. A Congressional Super Committee failed to find the required $1.2 trillion in cuts over ten years by a November 2011 deadline. The combined effect of lost taxpayer and user fees projected by Maryland-based Alliance for a Stronger FDA, would be an initial $294 million out of a $3.65 billion budget.

The catch comes from a component of FDA's user fee programs known as the "trigger" that requires a certain baseline of taxpayer funds to go to FDA, so industry user fees supplement rather than fund FDA's operations. FDA's projected funding for fiscal year 2013, set at $2.5 billion, would be cut by an across-the-board, 8% cut in federal government, coined as a "fiscal cliff", imposed to help curb the ever-increasing government debt. While FDA's cut of about $200 million would not normally hit the trigger to prevent FDA's use of user fees, Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, told Anna Edney from Bloomberg that the Obama Administration may still sequester FDA's user fee funds to help with federal spending reduction goals. The exact trigger levels, moreover, are based on formulas that include consumer inflation and past spending, which so far FDA has declined to comment on.

According to Grossman, if this occurs, about $68 million in drug and device user fees and $40 million in tobacco-company payments would be diverted to a U.S. Treasury Department account that would "reduce government because it would reduce what they can do." Faced with the sudden loss of these funds, drug industry experts have speculated that FDA would be forced to lay off personnel and take other measures to reduce costs.

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August 23, 2012

Learn the FDA Approval Process and the Ins and Outs of Post-Approval Challenges for Medical Devices

Thumbnail image for Thumbnail image for aci_header_banner.gifNow in its second year, ACI's FDA Boot Camp - Devices Edition has been designed to give products liability litigators, as well as industry in-house counsel, federal and regulatory affairs professionals, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. Learn from an experienced faculty of FDA regulatory attorneys whose sole purpose is to provide you with the information you need to remain compliant and in command. Don't wait until 2013 to hone your practice and to hear from a stellar faculty, led by a "who's who" of the nation's leading medical device regulatory lawyers, who will help you understand:

  • The basics of the application and approval processes, including 510(k) clearance and PMAs
  • The complexities of device regulations
  • The structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH
  • A practical working knowledge of clinical trials and IDEs
  • How devices are classified, monitored, and regulated
  • The pivotal role of labeling and learn how to avoid misbranding and off label promotion
  • The importance of cGMPs and QSRs to the post-approval regulatory process
  • The protocols of adverse events monitoring, product withdrawals, and recalls

Attend the pre-conference workshop to seamlessly join the FDA regulatory law discussions at the main conference. The perfect primer to accompany FDA Boot Camp, the pre-conference workshop: Fundamentals of FDA Device Regulatory Law, provides the FDA law refresher course essential to getting the most benefit from the main conference program.

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