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…when we at HPM usually get a call from a potential client wanting to appeal the approved labeling language. But, of course, such an appeal is not permitted as FDA…
…in comments from the National Association of Attorneys General. All of this is the long way to say that Congress’s concern about delays in the issuance of a final rule…
…detached from reality, so we thought it would be a worthy exercise to begin cataloguing the principal errors and mischaracterizations underpinning those attacks. Even if one presumes that FDA’s oversight…
…of product applications, particularly for flavored e-cigarettes. “I believe certain flavors are one of the principal drivers of the youth appeal of these products,” said Dr. Gottlieb (in March 2018,…
…PDDA to make this portal available). Importantly, SORS Online established more than just an online reporting method because DEA also for the first time required registrants to provide a “reason…
…website information regarding its enforcement activities, including: the names and judicial districts of all lawsuits filed by the government with regard to activity regulated by FDA; the names and judicial…
…risk exists if the conduct poses an actual or potential risk to patients or causes substantial financial loss to Federal health care programs, or indicates a pattern of misconduct Higher…
…a single misdemeanor misbranding charge, which alleged that the drug product’s labeling did not contain adequate directions for the intended uses. The misbranding charge is a strict liability offense. Allergan…
…Affordable Care Act. Paradoxically, the Trump Administration has joined a lawsuit brought by several states seeking to invalidate the Affordable Care Act in its entirety in a case pending before…
…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here). We find it all rather interesting. After all, data can provide an informative…
…with over 430 sites, and after that, several countries in Europe and in Asia each had over a hundred catalog sites, including Germany, Canada, Italy, France, Japan, the U.K., and…
…of the historical background that spurred Congressional action here, including national security risks highlighted by U.S. Departments of Defense (DoD) and Commerce actions against several specific Chinese biotechnology companies. An…
…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.” Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…
…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…
…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…