By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …
By James R. Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit …
By Kurt R. Karst – In a pair of Federal Register notices (here and here) set for publication on August 27, 2012, and in a pair of draft guidance documents released ahead of their announcement in the Federal Register next week (here and here), FDA …
By Ricardo Carvajal & Diane B. McColl – Back in April, FDA’s Center for Veterinary Medicine ("CVM") notified industry of its decision to extend the agency’s Memorandum of Understanding ("MOU") with the Association of American Feed Control Officials ("AAFCO") for one year (the MOU was scheduled to …
By Kurt R. Karst – The decades-long saga over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals is likely to continue for some time given an August 8, 2012 decision from the U.S. District Court for the Southern …
By Kurt R. Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House …
Hyman, Phelps & McNamara, P.C.’s Diane McColl will present at USP’s 2012 Science & Standards Symposium, which is dedicated to functional foods and dietary supplements. The conference will address scientific and regulatory issues from an international perspective, and will feature speakers from USP and NIH’s …
By Jennifer D. Newberger – Perseverance can be an admirable quality, except when it is misguided. So it seems to be with Representative Edward Markey and Senator Jeff Merkley, who seem intent on convincing the public that devices cleared through the 510(k) process pose great risks …
By Kurt R. Karst – Efforts to include a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership (“TPP”) agreement chapter on intellectual property rights are alive and well as folks ramp up for the 14th negotiating round of the TPP, which will take …
By Kurt R. Karst – It’s been nearly nine years since the enactment of the Medicare Modernization Act (“MMA”), which, among other things, changed the regime for 180-day generic drug marketing exclusivity from a “patent-by-patent” approach (under which shared exclusivity can exist for cross-Paragraph IV filers …
By Riëtte van Laack – The Organic Food Products Act of 1990 (“OFPA”) established national standards for the marketing of certain agricultural products marketed as organically produced. It directed USDA to issue regulations specifying the requirements for certification and labeling of organic agricultural products. In promulgating …
By Jennifer D. Newberger – On August 10, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This draft guidance largely mirrors the recently issued draft guidance for premarket approval applications, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on which we …
It’s that time of year again when we at FDA Law Blog turn to our loyal readers and ask for your help. The American Bar Association (“ABA”) announced that it is now accepting nominations for the 2012 Blawg 100 (the top 100 legal blogs – …
By Kurt R. Karst – That’s the picture conjured up when we plugged some dates into the new model for calculating forfeiture of 180-day generic drug marketing exclusivity for certain ANDAs – what we are calling “window ANDAs” – covered by Section 1133 of the recently …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) recently amended its regulations to allow practitioners to issue electronic prescriptions for controlled substances (“EPCS”) in lieu of hardcopy paper prescriptions. See 75 Fed. Reg. 16,236 (March 31, 2010). DEA requires that any electronic prescription …
