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…to support dismissal of other complaints with similarly defective allegations. The relator, Laurie Simpson, worked for seven years at Bayer Corporation, during which tenure she helped market and promote Trasylol,…
By Delia A. Stubbs – On Thursday, March 21, 2013, Representatives Harold “Hal” Rogers (R. Ky.), who is the co-founder and co-chairman of the Congressional Caucus on Prescription Drug Abuse,…
…and Legality in Drug Compounding Act of 2013, sponsored by Rep. Ed Markey; H.R. ___, Supporting Access to Formulated and Effective (S.A.F.E.) Compounded Drugs Act, sponsored by Rep. Rosa DeLauro. …
…generic equivalents. They also clarified that for self-administered drugs or biologics, communications about the entire drug delivery system, such as an insulin pump are considered communications about the drug itself. …
…and antiinfective drugs . . . experienced the fastest reviews, on the order of 10-15 months,” while “[f]or other categories – cardiovascular, central nervous system, gastro-intestinal, respiratory, etc. – average…
…apply to foreign entities that market covered products in the U.S., as well as to entities that do not manufacture covered products themselves, but instead hold FDA approval, licensure, or…
…on supplies) drug sampling and advertising. Thus, companies should be sure to review state laws and regulations, in addition to the federal CSA, when designing and implementing their corporate compliance…
…such as pharmacies and physicians, importers, exporters, and anyone in possession of the drug to the applicable provisions of the CSA and its implementing regulations, including administrative, civil and criminal…
…court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to other areas of FDA law, particularly as it relates to…
…misbranded: If it is a drug, or an [API], and it was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required…
…for line extensions of oral solid dosage form innovator drugs, not only to new formulations, but new indications, combination products, and products marketed by companies independent of the company marketing…
…the label of the brand-name, Reference Listed Drug (“RLD”) manufacturer (whose drug product is approved under an NDA) preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers…
By Jennifer D. Newberger – On Tuesday, April 17, 2012, Senators Burr and Coburn introduced the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act, or the “PATIENTS’ FDA…
…initiated by persons or entities that are completely independent of the relevant firm, including health care professionals, health care organizations, members of the academic community, formulary committees, patients, and caregivers. …
…of medical gases, and includes several miscellaneous provisions, such as provisions on prescription drug abuse, 180-day generic drug marketing exclusivity, citizen petitions, controlled substances, and nanotechnology to name a few. …