…the MFN price is used for years five through seven. Price increase penalty: To counteract the incentive for manufacturers to increase their prices in the commercial market to subsidize lower…

…compounding. Furthermore, the Committee encourages FDA and the States to work together to improve and strengthen oversight and enforcement of compounding pharmacies. Abuse-Deterrent Drugs.—The Committee supports FDA’s recent efforts to…

…the lapse period. Generally, scheduled advisory committee meetings regarding the approval of, or postmarketing safety issues regarding, products within the scope of the PDUFA, GDUFA, or MDUFA programs may go…

…once the drug is approved, the sky would be the limit for the company to make other claims that would lead to larger sales.  This perception, however, ignores other reasons…

…to DEA based on the quantity of kilograms involved. 1318.06(b)(1). DEA sells cannabis to the buyer at the negotiated sale price plus the assessed administrative fee. The buyer pays the…

…company, or that they are incompetent.  Rather, it is more persuasive to focus the presentation on the facts, and to avoid questioning the good faith, competence or motives of the…

…fee, and exclusion from the requirement to offer discounted prices to certain covered entities under the 340B program.  According to the preamble, certain of the comments identified plasma protein therapies,…

…entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. The exception for “willful misconduct” is exceedingly narrow. As mentioned, the immunity from liability…

…the Louisiana Wholesale DrugCompany, Inc., CVS Pharmacy, Inc., Rite Aid Corporation, Walgreen Co., Eckerd Corporation, The Kroger Co., Safeway Inc., Albertson’s, Inc., Hy-Vee, Inc., and Maxi Drug, Inc. provide in…

…in the remaining subset(s) without requiring a postulation of clinical superiority.  To obtain such a designation, however, the sponsor must demonstrate that, at the time of its designation request, the…

…of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 384, to allow for the importation of certain prescription drugs from Canada. Under the Final Rule, states…

…approval, it is the combination of the information from the four INDs that provided sufficient data to support the approval of the single NDA for BRAFTOVI® (NDA 210496).” To that…

…to the law (and specifically to the 180-day exclusivity forfeiture provisions)? A: One day.  On December 9, 2003, Sen. Hatch suggested changes to the failure-to-market 180-day exclusivity forfeiture provision.  See 149…

…seek equitable relief, S. 4626 and H.R. 2668. Indeed, earlier this week, the full Commission testified before the U.S. Senate Committee on Commerce, Science, and Transportation and submitted testimony on…

…that FDA’s approval of Mitigare was consistent with the FDCA, the regulations the agency has promulgated pursuant to the FDCA, the Citizen Petition Responses FDA has issued, and the policies…