By Ricardo Carvajal – FDA published a Federal Register notice asking for nominations of individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee ("TPSAC"). The TPSAC has been ensnared in controversy due to allegations of bias and conflicts of interest among current …
By Kurt R. Karst – In a Report to Congress issued earlier this year and recently made public, FDA’s Rare Disease Group (“RDG”) and Neglected Tropical Disease Group (“NTDG”) report on their findings and recommendations to improve the current regulatory/scientific armamentarium to facilitate the development of …
By Kurt R. Karst – On August 31, 2011, the Federal Trade Commission (“FTC”) announced the issuance of its final report, titled “Authorized Generic Drugs – Short-Term Effects and Long-Term Impact,” which has been in the works for years since it was requested in 2005 by …
By Anne Marie Murphy – This week FDA announced the publication of a draft guidance titled, “Oversight of Clinical Investigations: A Risk Based Approach to Monitoring.” This is the first time since 1988 that the agency issued a specific guidance document on how a study sponsor …
By Ricardo Carvajal – In June, we reported that the DC Circuit Court of Appeals decided it lacked exclusive jurisdiction over a Natural Resources Defense Council (“NRDC”) citizen petition seeking FDA action against BPA. Undeterred, NRDC has now filed its complaint in district court. The complaint …
By Kurt R. Karst – On August 29, 2011, Public Citizen announced that it submitted a citizen petition to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected (“CBE”) and Prior Approval Supplement (“PAS”) …
By Riëtte van Laack – Under the law, a manufacturer of a new dietary ingredient ("NDI") or a dietary supplement containing an NDI must notify FDA of the basis for the manufacturer’s conclusion that its product “will reasonably be expected to be safe.” FDA’s regulation, 21 …
By Ricardo Carvajal – Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. ("PAO"), a Guatemalan producer that is one of Del Monte Fresh’s principal suppliers. FDA imposed the import alert …
It’s that time of year again when we at FDA Law Blog turn to our loyal readers and say: “Our fellow Blogerians, Ask not what your blog can do for you – ask what you can do for your blog.” Yes, the American Bar Association …
By Kurt R. Karst – Recently we reported on the “other battle” going on concerning patents listed in the Orange Book for The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) Injection. With patent reform reportedly high on President Obama’s agenda, and with the fast approaching September 6th return of …
By Cassandra A. Soltis – In response to the Food and Drug Administration’s (“FDA’s”) proposed rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments, members of the U.S. Senate and House of Representatives have requested that FDA exclude grocery stores …
By Kurt R. Karst – Earlier this week, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a four-count Complaint against FDA in the U.S. District Court for …
By Jennifer D. Newberger – On August 15, 2011, FDA released two Draft Guidances: “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices.” Each is discussed in turn below. Factors to Consider when Making …
By Kurt R. Karst – The court battle over the “new drug” status of Cody Laboratories, Inc.’s and Lannett Co., Inc.’s (collectively “Cody/Lannett’s”) Morphine Sulfate Oral Solution 20mg/mL drug product has taken a new turn. FDA’s Motion to Dismiss the case on mootness grounds has been …
By Riëtte van Laack – FDA is reopening the comment period on the proposed rule it published on December 8, 2010, to amend the regulations on plant sterol/stanol esters and risk of coronary heart disease. (See our previous post on the proposed rule.) One of FDA’s proposed …
