On March 5, 2008, FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed collection of information concerning the new clinical trial certification requirement created by Title VIII of the FDA Amendments Act (“FDAAA”). We previously reported on …
In recent years, FDA has studiously avoided taking any broad regulatory action on the issue of whether, and under what circumstances, the presence of methylmercury in fish renders that fish adulterated. FDA recognized that the scientific evidence that addresses the potential risks posed by methylmercury …
FDA released a Memorandum of Agreement Between the Office of New Drugs (“OND”) and the Office of Surveillance and Epidemiology (“OSE”) in the Center for Drug Evaluation and Research (“CDER”) “on the management of significant safety issues associated with pending and approved drug products.” The …
As we previously reported, in August 2007, FDA issued a letter and started a docket requesting public comment on a variety of 3-year exclusivity issues concerning generic versions of Shire U.S. Inc.’s PROAMATINE (midodrine hydrochloride) Tablets. FDA approved PROAMATINE in September 1996 under the Agency’s …
Now that FDA has set the Fiscal Year 2009 Prescription Drug User Fee Act (“PDUFA”) user fee rates and is preparing invoices for delivery (payable by October 1, 2008), a quick review of the options available to companies to request user fee waivers and reductions …
Massachusetts has now joined California and Nevada in imposing marketing compliance obligations on drug and device companies marketing products in the state. On Sunday, August 10th, Massachusetts Governor Deval Patrick signed into law Senate Bill 2863, which requires the Massachusetts Department of Public Health (DPH …
In the coming days, President Bush is expected to sign into law H.R. 6432 – the Animal Drug User Fee Amendments of 2008. The new law reauthorizes and amends the Animal Drug User Fee Act (“ADUFA”) through Fiscal Year (“FY”) 2013, creates a new law …
Off-label use cases have certainly become the rage. Last week, the federal government’s Government Accountability Office released a report that outlined the government’s enforcement efforts in this area. The report casts doubt on FDA’s ability to monitor off-label drug promotion. In addition, a number of …
Representative John Dingell (D-MI) has revised several of the drug-related sections of the Discussion Draft of the FDA Globalization Act (“FDAGA”). We first reported on the Discussion Draft, which has received significant attention from industry and stakeholder groups alike, in April 2008. Updated sections of the …
Yesterday, Pharmalot reported that U.S. Senator Herb Kohl (D-WI) and several co-sponsors introduced the “Independent Drug Education and Outreach Act of 2008.” A similar version of the bill has reportedly been introduced in the U.S. House of Representatives. According to a press release from …
On August 1, 2008, FDA will publish a Federal Register notice announcing the Fiscal Year (“FY”) 2009 user fee rates established under the Prescription Drug User Fee Act (“PDUFA”). A similar notice will also be issued with the FY 2009 user fee rates established under …
On July 15, 2008, FDA issued a final rule exempting investigational drugs used in phase 1 studies (as described in 21 C.F.R. § 312.21 of FDA’s IND regulations) from the Current Good Manufacturing Practice (“CGMP”) requirements in 21 C.F.R. Part 211. This exemption does not …
When Congress enacted the Federal Food, Drug, and Cosmetic Act (“FDCA”) in 1938, it required New Drug Applications (“NDAs”) for “any” new drug. At the time, approximately half of the drugs in this country were compounded, not manufactured. Today, while the percentage of compounded prescriptions …
On July 18, 2008, in a rare “win” (depending on which side you are on) on a motion for reconsideration, the U.S. District Court for the Southern District of Indiana (Indianapolis Division), vacated the court’s September 2007 decision in Tucker v. SmithKline Beecham Corp., in …
On June 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) announced the release of a newly revised version of the “Code on Interactions with Healthcare Professionals,” which is a voluntary code focusing on the industry’s interactions with healthcare professionals as they relate to …
