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…criminal investigators assigned to a case. If recording statements is good policy for DOJ (the principal litigator for the U.S. government, and a significant investigative agency), then other agencies—including FDA’s…
…on proposals to withdraw approval of all subtherapeutic uses of penicillin in animal feed and nearly all subtherapeutic uses of tetracyclines (oxytetracycline and chlortetracycline) in animal feed, as well as…
By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association (“GMA”) announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe…
By Ricardo Carvajal & Diane B. McColl – In Part 1 of our effort to characterize the principal errors and mischaracterizations underpinning attacks on the GRAS exception, we focused on…
…forum shopping starkly contrasts with “the old days” when FDA criminal cases were almost always brought in the company’s principal place of business. This trend is troubling for companies because…
…render a product “distinct,” and therefore subject to FDA pre-approval. The complaint also alleges that the Final Guidance sets forth final agency positions, imposes legal obligations, establishes consequences for non-compliance,…
…interval 0.66 to 0.95); however no information was provided on whether the CRL was a material event to the applicant in more of the BLA cases than the NDA cases….
…of Directors, first as vice chair and later as chair. More recently, Frank served as the principal analyst and author of a seminal report, titled “Quantum of Effectiveness Evidence in…
…also allowing additional time for compliance with the supply chain program requirements of the animal food rule, under certain circumstances. The range of potentially applicable compliance dates is sufficiently complicated…
…to FDA information that must be included in the labeling of food (the NFB; ingredient statement, and any natural or artificial flavoring; any applicable allergy statements; nutrient content claims; health…
…heart disease, site specific cancers, diabetes, hypertension, osteoporosis, age-related macular degeneration, neural tube defects, and dental caries.” One of the principal objectives of the NRP was to develop a proposed…
…with history of highly symptomatic atrial fibrillation/flutter. To the extent FDA Law Blog readers are aware of additional clinical superiority approval precedents, we’re all ears. Greater Effectiveness Clinical Superiority Determinations…
By Riëtte van Laack – On August 17, FDA published in the Federal Register the long awaited final rule, “Substances Generally Recognized as Safe.” The final rule is based on…
…composed of large molecules (macromolecules), a drug that contains the same principal molecular structural features (but not necessarily all of the same structural features) and is intended for the same…
…contains “the same principal molecular structural features (but not necessarily all of the same structural features)” as the previously approved drug. FDA further defines structural “sameness” for different types of…