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…between FDA and Senators Hatch and Harkin, Commissioner Hamburg committed to issuing a revised draft in order to address the concerns of Congress and industry. Four years later, in August…
…into arrangements with foreign governments to recognize the inspection of foreign establishments that are registered under the FDCA “…in order to facilitate risk-based inspections…” FDASIA section 712 (FDCA section 809):…
…days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a district court denial of a motion to dismiss filed by a defendant indicted for illegally…
…Order which shall commence on the date this Order is mailed. Pilgram, 82 Fed. Reg. at 11,059 n.4. While this practice still does not clear up other concerns with DEA…
…of the best trained and most experienced doctors and make it available to other doctors. Yet, the latter are likely to rely more heavily on the software recommendations than would…
…the Agency received numerous comments from industry and Congress. These positions include: “Grandfathered” ingredients. The Agency narrowly construes the category of “grandfathered” (or “old”) dietary ingredients, i.e., those that are…
…a number of UK drug facilities from EU oversight over the coming years. In a recent interview, Ms. Corrigan said that $18.5 million in inspection costs could be used elsewhere…
…suspicious order reporting and monitoring. DEA stated that, short of providing arbitrary thresholds to distributors, “it cannot provide more specific suspicious orders guidance because the variables that indicate a suspicious…
…not misleading is limited: It is also not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of…
…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…
…whether they complied with human subject protection guidelines; a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and …
…Order granting the government’s motion for an Order to Show Cause. We will post a more detailed analysis of the Bayer case and its potential effects in the coming days. …
…their patients.” (FN 5). FDA notes that hospital compounding and distribution varies: Some compound only for use and administration within the hospital and others compound for distribution throughout a broader…
…provides an example: [I]f Applicant X experiences an interruption in manufacturing of the 50-milligram (mg) strength of a drug product that would be subject to § 314.81(b)(3)(iii), but the 100-mg…
…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…