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…in order to address the growing problem of drug shortages. In her statement before the Senate Committee on Health, Education, Labor, and Pensions, GAO Director of Health Marcia Crosse stated…
…as the EPA compliance order in Sackett. Unlike that order, FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. Such…
…the October 2011 emergency order) as part of FDASIA. Methylone is the only substance from that order that Congress did not legislatively add to Schedule I when it enacted FDASIA,…
…Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, has paid off. FDA, following an April 12, 2013 Order from the U.S. District Court…
…Consider, for example, the order of NDA approval. FDA’s long-standing position has been that in order for a fixed-dose combination drug to be eligible for 5-year New Chemical Entity (“NCE”)…
…feature of the bill. The draft also requires that all compounding pharmacies comply with both USP <795> (non-sterile compounding) and USP <797> (sterile compounding). The draft proposal emphasizes sharing of…
…unobserved. It was not raised as an issue to address in FDASIA last year, and manufacturers don’t seem to be complaining about FDA’s failure to comply with its statutory mandate…
…by reference portions of the other brief, we will refer to the parties submitting the two briefs collectively as “POM.”. POM argues that the Order bans constitutionally protected speech. It…
…first decision dealing with the 180-day notice of commercial marketing provision at PHS Act § 351(l)(8)(A) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) since the…
…in support of the motion, the complaint “presents ‘abstract hypotheticals or requests for advisory opinions’” and must fail on standing or ripeness. The government contends that the plaintiffs, who filed…
We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay…
…Columbia seeking declaratory and injunctive relief concerning the company’s non-crush-resistant formulation of Opana® ER approved under NDA No. 021610 (identified in Endo’s Complaint as “Original Formulation Opana® ER”). Endo alleges…
…only 500 characters to say why you’re a fan of the blog, so you’ll have to keep your remarks pithy. Remember, when you complete the nomination form, our URL is…
…located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR…
…comment or discuss any website on that website. The comments are available to any user of Google toolbar and appear in association with a particular website, although the comments are…