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…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…
…pathway to transition adult smokers off combustible cigarettes, in light of the increased use by minors, the Agency is now seriously reconsidering the extension of compliance dates for the submission…
…also reflected in FDA’s online database: Recognized Consensus Standards. The Draft Guidance explains that there are two “primary situations” where FDA may decide to withdraw recognition of a standard: (1)…
…4205 and 80 comments on the draft guidance, and considered all those comments when drafting the proposed rules. FDA estimates that the initial mean cost of complying with the proposed…
…Function Device Products draft guidance, working model, challenge questions, and roadmap, in addition to holding in person and online sessions, demonstrate FDA’s commitment to be transparent and build collaboratively. Interested…
…complaints associated with the products. FDA is planning on sending additional letters to other manufacturers and has asserted that companies that do not comply will be in violation of the…
…conveys disease treatment or prevention. FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that…
…and himself, Mr. Sasinowski offered four recommendations: Proposal #1: FDA should consider the appropriateness of the Accelerated Approval process for every new therapy. Proposal #2: FDA and sponsors should use intermediate clinical…
…online ads. Under the consent orders, the companies may not make such representation unless they have evidence to support the claim. They must have competent and reliable evidence to substantiate…
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…that this product is either not included on most third party payor formularies due to the availability of generic equivalents, or, where it is covered, it is placed on non-preferred…
…and a separate study in patients with sBCC.” FDA disagreed, and concluded that a well-designed study in AK will suffice to show bioequivalence of a generic version of ALDARA: [T]here…
…Complaint opens with the following salvo: This action is brought as a result of Defendants’ relentless efforts to obstruct and constrain competition through an admittedly “anti-generic strategy.” Through multiple, concerted, and…
By Kurt R. Karst – Earlier this week, iPR Pharmaceuticals, Inc. (“iPR”), the owner of NDA 021366 for CRESTOR (rosuvastatin calcium) Tablets, 5 mg, 10 mg, 20 mg, and 40…