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…advisory committee meeting is warranted. The SIA limits the number of advisory committee meetings FDA must convene per sunscreen TEA and per year. The combination of FDA’s limits on what…
…(pregabalin) – one for U.S. Patent No. 6,001,876 with respect to NDA No. 21-723, and another for U.S. Patent No. 6,197,819 with respect to NDA No. 21-446. FDA also approved…
…tentative approval to conform the status of the ANDA to the district court’s June 2007 Order issued pursuant to 35 U.S.C. 271(e)(4). That Order (as amended) states in relevant part:…
…drug for unpatented uses so that it can quickly come to market. The statute thus contemplates that one patented use will not foreclose marketing a generic drug for other unpatented…
…Manufacturing, and Fostering Broad Based Growth: 100-Day Reviews under Executive Order 14017, 52% of all FDA-registered finished dosage form manufacturing facilities and 73% of all FDA-registered API-manufacturing facilities were located…
…the order of events (i.e., a final court decision and tentative approval), the Court’s conclusion (emphasized above) is pretty clear under the statute: if “any other applicant” (i.e., a subsequent…
The Federal Circuit’s March 22, 2007 decision invalidating Pfizer’s patent on NORVASC (amlodipine besylate), and Mylan’s commercial launch of its generic version approved under ANDA #76-418 later that day triggering…
…2016, FDA issued a request for comments regarding the establishment of duration of medically important antimicrobial drugs that currently do not have a duration limitation. The comment period closed March…
…FDC Act jurisprudence. Also, because the recipient of the instant Warning Letter is a foreign firm, the company’s refusal during the inspection results in a ban of that company’s products…
…Subtitle E are summarized in turn below. PART 1: MAXIMUM FAIR PRICE PAYMENT LIMITATION UNDER MEDICARE PARTS B AND D AND THE COMMERCIAL INSURANCE MARKET The most far reaching drug…
In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising…
…reviewed by FDA’s Arthritis Advisory Committee on February 9, 2016 (FDA briefing document here). The Committee recommended approval by a vote of 21-3, with the three no votes apparently tied…
…price in any “high income country” (defined in the Act as the U.K., Germany, Canada, and Australia), the manufacturer was presumed to be in violation of the law. The burden…
…managing re-training risks. It stated: Deployed models have the capability to be monitored in “real world” use with a focus on maintained or improved safety and performance. Additionally, when models…
…Grain Meat Co., Finless Foods, Hungry Planet, Impossible Foods, Lightlife, Sweet Earth Enlightened Foods and the Tofurky Company (collectively GFI) also oppose the USCA Petition. GFI’s comments focus primarily on…