…(e.g., data on Paragraph IV certification filings and 180-day exclusivity), says that the bottom line is that although “authorized generics have a substantial effect on the revenues of competing, generic…

…predicate devices, learn FDA’s existing data requirements, and/or extrapolate likely additional data requirements that might apply.  Unfortunately, the essential information is not easily available.  The database of 510(k) summaries is…

…FDA’s confidence in the ability of generic manufacturers to perform ongoing pharmacovigilance duties – which makes sense, given their substantial scientific and financial resources, as well as the effort they…

…body in the United States, reviewed an advertisement for one of Maybelline’s “Eraser” line of cosmetics and came to a slightly different conclusion.  NAD Case #5241, Maybelline New York Inc.,…

…a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot…

…to be withdrawn as a condition of the Bromday approval,” and the lawsuit ensued.  ISTA argues in its court filings that FDA’s approval of Coastal’s ANDA and FDA’s denial of…

…wins the suit, it receives the [180-day exclusivity] bounty.  If the generic firm instead loses the suit, it loses the exclusivity.  Nor can it receive the bounty if it settles…

…would render the drug products less safe or less effective than Xyzal for the remaining conditions of use. The decision also gives us good reason to update our popular Generic…

…the door to a possible forfeiture of 180-day exclusivity under FDC Act § 505(j)(5)(D)(i)(IV) for failure to obtain tentative approval within 30 months of ANDA submission, it also raises questions…

…about last year. OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches…

…technology; ethical considerations in the labeling of biologically active foods; and predictions for the future of food labeling and regulation.  A brochure with additional information is available here and on-line…

…any specific obstacles to the disposal of controlled substances in your community or geographical area? If so, what are they? How is the disposal of controlled substances affected by State…

…anything, the final rule makes a number of AMP issues more murky than they were before. The preamble does contain some clarifications regarding the effect of the withdrawal of the…

…of milk derived from cows not treated with rbST continues more than 15 years after that drug’s approval (rbST stands for “recombinant bovine somatotropin,” a bioengineered hormone that increases milk…

…processes, with specific timelines, for FDA to review ingredients for safety, set safety levels for trace impurities (called nonfunctional constituents),  and review all safety determinations made by the Cosmetic Ingredient…