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…in 2019 that may shape future FDA regulation. We hope this report proves useful and interesting to you. For more information about HP&M, please go to our website at www.hpm.com….
…6 months of pediatric exclusivity (until June 2, 2013). FDA, following the explanation provided in the Agency’s March 27, 2012 Letter Decision, [http://www.hpm.com/pdf/blog/SEROQUEL%20-%20FDA%20Letter%20Decision%203-27-2012.pdf] primarily argued that the scope of 3-year…
…outside counsel, distinguished in-house counsel and compliance officers, as well as 9 government enforcers and regulators. They will help those in attendance: REASSESS compliance programs as a result of the…
…the regulatory review period, in which the company argued that August 8, 1995 is the controlling date for PTE purposes. On May 7, 2008, FDA denied Wyeth’s request. FDA’s letter…
…Policy Book. In support of its petition, USCA discusses the definition of “meat” and “beef” in common dictionaries and by USDA, the Federal Trade Commission’s (FTC’s) truth in advertising standard,…
…antimicrobial drugs in animals. See 73 Fed. Reg. 38110 (July 3, 2008). However, after extending the comment period, and receiving numerous substantive comments, only few of which supported the order,…
…some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). In the last decade, federal agencies including FDA and APHIS, have taken a number of…
…are all animals other than the 7 major species (dogs, cats, cattle, horses, swine, chickens, and turkeys). The Act was intended to increase drug availability by modifying the Federal Food, Drug,…
…as “equal to or less than 50,000 horses; 70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 turkeys; and 72,000,000 chickens.” In the Federal Register notice announcing the final rule,…
…performance standards for Salmonella on beef carcasses, ground beef, pork carcasses, chicken carcasses and parts, comminuted chicken, turkey carcasses, and comminuted turkey. FSIS also developed performance standards for Campylobacter on…
…the CSA to identify products containing anabolic steroids. It is now unlawful to import, export, manufacture, distribute, dispense, or possess with intent to manufacture, distribute, or dispense an anabolic steroid…
…include muscle cuts of beef (including veal), lamb, chicken, goat, and pork; ground beef, ground lamb, ground chicken, ground goat, and ground pork; wild and farm-raised fish and shellfish; perishable…
…to foods comprised of or containing cultured seafood cells, what attributes (such as nutrition, taste, texture, or aroma) vary between the foods and should FDA consider to be material to…
As readers of this blog may recall, the issue of the regulation of meat and poultry derived from cell lines, identified by such terms as cultured meat, clean meat, and…
…ideal candidate will have experience working at FDA or with a medical device company, and prior big law firm experience is helpful. Compensation is competitive and commensurate with experience. HP&M…