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 …
On August 8, 2008, the U.S. Court of Appeals for the Third Circuit issued an opinion in an appeal from a conviction under, among other provisions, the criminal provisions of the Federal Food Drug and Cosmetic Act (“FDC Act”). A jury convicted Eric Goldberg of …
The Weston A. Price Foundation has submitted a citizen petition asking FDA to revoke its regulation approving a health claim for soy protein and coronary heart disease. According to the petition, in light of studies published since the regulation was issued in 1999, “[t]he totality …
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 …
On August 14, 2008, the President signed into law Public Law No. 110-314, the Consumer Product Safety Improvement Act of 2008. The new law contains a number of provisions relating to children’s products, including lead. It also contains provisions relating to the administrative functions that …
When Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 to require source declaration for ingredients derived from major food allergens, Congress chose not to include any requirements with respect to so-called advisory labeling (e.g., “may contain peanuts,” or “processed in a …
Robert A. Dormer of Hyman, Phelps & McNamara, P.C. will be speaking at American Conference Institute’s FDA Boot Camp conference, September 22-23, 2008 at the Sheraton Boston Hotel in Boston, MA. Click here for a copy of the agenda. At the event, preeminent members of the …
A recent Federal Trade Commission (“FTC”) action serves as a reminder that the agency takes seriously cases referred to it by the National Advertising Division of the Council of the Better Business Bureaus (“NAD”). In a press release issued earlier this week, the FTC announced …
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 …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’ s Gwendolyn M. McKee and John R. Fleder discusses the potential consequences to company executives and companies of submitting false information to a government agency, even when the submission is not made under oath. …
On September 8, FDA will hold a public meeting to receive data and other information on the effects of nanoscale materials on quality, safety, and effectiveness of FDA-regulated products. FDA will consider the information that it receives in its development of guidance that addresses: (1) …
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 …
