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…that must be submitted to the clinical trials data bank, www.ClinicalTrials.gov. One of the provisions requires that a certification of compliance accompany certain human drug, biological, and device applications and…
…the recommended practices: such adherence “may, in some cases, facilitate admissibility determinations.” Comments on the draft guidance should be submitted by April 12, 2009 to Docket No. FDA-2009-D-0675 at www.regulations.gov….
…while reducing diversion. John Gilbert of HPM will be speaking at the conference along with other government and industry representatives. More information on the conference can be found at: http://www.fdli.org/conf/446/index.html….
…Case studies, hypotheticals, and ample time for Q&A are provided. To learn more and to register for the conference, visit www.fdli.org/programs. Use discount code “save15” to save 15% off your…
…FDA conducted a webinar on the guidance on February 19, 2016, which can be found here: http://www.fda.gov/Training/CDRHLearn/. In addition, we believe an agency FAQ document may be beneficial for enhanced…
…Compendium, which will be available at www.fda.gov/COACompendium, is supposed to provide clinical trial sponsors a database of: (1) qualified tools; (2) ongoing qualification programs; and (3) previously labeled COAs (from…
…challenging to identify discrete opportunities. However, we believe those companies facing near term generic competition have the strongest motivation to consider this strategy in order to capture residual intellectual property…
…MMA, 180-day exclusivity was triggered by the earlier of: (1) the first commercial marketing of the drug by a first filer; or (2) “the date of a decision of a…
…interpretations of the forfeiture provisions.” Upsher-Smith Laboratories (“USL”) and Teva Parenteral Medicines (“Teva”) submitted comments to docket #2007N-0417. (The deadline for submitting comments to the docket has been extended from October…
…things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated guidance for media and developed a website called “Fat Foe” that mimics commonly used…
Companies are embracing corporate social responsibility (CSR) more and more; it is a way for companies and brands to incorporate the company’s values into their business model, and engage with…
…orders. Finally, last Wednesday, DEA announced that is adding to its ARCOS Online Reporting System the ability for manufacturers and distributors “to view the number of competitors who have sold…
…alone would be worth the price of admission (if admission weren’t free). Those coming late to the party can still join in remotely by registering for the online webcast here….
…it intended to constitute a comprehensive review of the subject. Nonetheless, the summary may be of use to those who were unable to attend the workshop and have an interest…
…since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. The online records…