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…approximately 2 p.m. EDT. The deadline to register for oral comment is 11:59 p.m. EDT, Aug. 15. https://www.ams.usda.gov/event/listening-session-organic-livestock-and-poultry-standards. Comments to the proposed rule may be submitted until Oct. 11, 2022….
…Health. These figures are borne out by manipulating the publicly available inspection database from FDA which can be found here. While the numbers don’t line up exactly with Capt. Boyd’s…
…other control or influence . . . it is not responsible for the content on that site.” Id. at 4. Likewise, “[i]f a firm is merely providing promotional materials to…
…a medical device 23. More festive, as apparel 24. Invokes section 302 28. Some preclinical subjects 30. ___ Mack (long-serving manager) 31. Sec. 502(g) compendium 34. Boy band started in…
…Kroger Co., C&S Wholesale Grocers, Inc., Associated Wholesale Grocers, Inc., McLane Co, Inc., Procter & Gamble Co., Tyson Foods, Inc., and Kraft Heinz Co. It is possible the FTC will…
…treating physicians’ decisions concerning the standard and methods of care available to terminally ill patients.” S. 3506 – The Ethical Pathway Act of 2012 S. 3506 was introduced by Sen….
By Kurt R. Karst – Earlier this week, Rep. Jan Schakowsky (D-IL), along with Reps. Ed Markey (D-MA) and Tammy Baldwin (D-WI), introduced H.R. 5786, the Safe Cosmetics Act…
…company at the heart an outbreak of salmonellosis five years ago that was traced to the company’s peanut products. In particular, PCA owner Stewart Parnell was convicted of conspiracy, mail…
…definition of marijuana. THC not “in hemp” also remains controlled under the CSA as a schedule I controlled substance. Hemp, like marijuana, derives from the Cannabis sativa plant. Unlike marijuana,…
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to…
…available only behind the counter. Specifically, the petition asks FDA “to remove sales of [SJW] from Herbal Dietary Supplement to behind the pharmacy counter status to Pharmacists-Only Class of Drugs…
…initial determination on 180-day exclusivity eligibility . . . right? Not so fast! That was the case . . . until recently. As our friend Bob Pollock over at Lachman…
…its position by quoting Bracco Diagnostics v. Shalala, 963 F. Supp. 20, 28 (D. D.C. 1997). FDA always quotes the district court’s statement that: “The MBI products and plaintiffs’ products…
…drug Makena. K-V Pharm. Co. v. FDA, 889 F. Supp. 2d 119, 137 (D.D.C. 2012). (the decision was vacated and remanded, citing Cook v. FDA, 733 F.3d 1 (D.C. Cir….
…the hands by grease and other oils.” FDA will address these products in future rulemaking. The final rule is effective 1 year after it was issued, i.e., September 6, 2017….