Search Results for: brian malkin

On Sunday, February 16, BioCentury This Week television examined the policies surrounding the expected competition of innovator biologic products with biosimilar versions. Featured in the program were interviews with: Geoffrey Eich, Executive Director of R&D Policy at Amgen Inc. Craig Wheeler, President & CEO of Momenta Pharmaceuticals Inc. Brian Malkin Partner at Frommer Lawrence & […]

FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: “Innovative Strategies for New Product Development” on February 5, 2014. The program will be held at the Montgomery County Department of Economic Development offices at 111 Rockville Pike, 8th Floor, Rockville, Maryland 20850 from 8-10 am. Planned topics include: Drug […]

On January 30, 2014, FLH Partner Brian J. Malkin will speak at the New York State Bar Association’s (“NYSBA’s”) Annual Meeting of the Food, Drug and Cosmetic Law Section. Mr. Malkin will introduce and speak with Molly Muldoon, FDA’s former Chief of Staff, on “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and […]

On January 28, 2014, FLH Partner Brian J. Malkin will speak on a panel “Understand the FDA Report [Risk Evaluation and Mitigation Strategies (“REMS”) Standardization] and the Impact on the Industry” at ExL Pharma’s 6th Risk Evaluation and Mitigation Strategies Summit held on January 28-29, 2014 in Alexandria, Virginia. Joining Mr. Malkin in the panel […]

On January 6, 2014, FLH Partner Brian J. Malkin was quoted in an article by Derrick Gingery in The Pink Sheet entitled “Generic Drugs 2014: OGD Creates Internal Review Goals, May Make OND-Inspired Changes”. Gingery’s article focused on FDA’s Office of Generic Drugs (“OGD”) taking steps to meet review deadlines that will be imposed by […]

On February 5, 2014, FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: “Innovative Strategies for New Product Development”. The event will be held at the Montgomery County Department of Economic Development offices in the Shady Grove Innovation Center, 9700 Great Seneca Highway, Rockville, Maryland 20850 from 8-10 am. […]

FLH Partner Brian J. Malkin will join more than 700 generic industry professionals and FDA staff who attend the Generic Pharmaceutical Association’s (“GPhA’s”) Fall Technical Conference in Bethesda, Maryland from October 28-30, 2013. This unique educational conference has become the vehicle for key FDA officials to disclose and discuss the key regulatory and technical issues […]

On October 24, 2013, FLH Partner Brian J. Malkin was quoted on an Inside Health Policy article “FDA Denies Shared REMS Petition; But Guidance, Rulemaking A Possibility”. Some background on this topics may be found in a previous blog here. Building upon a recent presentation made at the FDA public meeting on Standardizing and Evaluating […]

On September 30, 2013, FLH Partner Brian J. Malkin was quoted in an article in “The Pink Sheet” entitled “GDUFA Plus One: Stakeholders, FDA Confident As Review Goals Near” (subscription or article fee required). The article summarized progress since the Generic Drug User Fee Act (“GDUFA”) was enacted last year. GDUFA permitted FDA to collect […]

On September 11-12, FLH’s Partner Brian J. Malkin will attend GPhA[Generic Pharmaceutical Association]/FDA’s ANDA [Abbreviated New Drug Application] Labeling Workshop / USP [United Pharmacopeial Convention] User Forum. The Conference provides a unique opportunity for attendees to hear straight from FDA’s Office of Generic Drugs (“OGD”) Labeling Review Staff, who are responsible for reviewing and approving […]