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Ex-FDA Head Gottlieb Expects Virus Spreading in U.S.

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Former FDA commissioner Scott Gottlieb expects the U.S. to see the coronavirus further spreading across the nation, and globally h...

ActiPatch Cleared for Musculoskeletal Pain

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FDA clears a BioElectronics 510(k) for its over-the counter ActiPatch medical device and an expanded indication adjunctive treatm...

EyeYon Medical Gets Breakthrough for EndoArt

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FDA grants EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant.

Romark Seeks BE Restrictions on Alinia Generics

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Romark Laboratories asks FDA to require several bioequivalence tests for any ANDA citing Romarks Alinia as the reference-listed pr...

Animal Models for Antibacterial Development Workshop

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FDA announces a 3/5 workshop on Advancing Animal Models for Antibacterial Drug Development.

FDA/FTC Workshop on Biologic Anticompetitive Behavior

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Federal Register notice: FDA and the Federal Trade Commission announce a 3/9 public workshop: FDA/FTC Workshop on a Competitive Ma...

Balance of Nature Marketing Unapproved, Misbranded Drugs: FDA

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FDA warns Balance of Nature that it is marketing dietary supplements that the agency considers to be unapproved and misbranded new...

Recurring QS Violations at Won Industry

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FDA warns South Koreas Won Industry Co. about Quality System and other violations in its manufacturing of the Morning Life Compres...

Sanfilippo Syndrome Drug Development Guidance

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FDA issues a draft guidance on developing drugs to treat Sanfilippo syndrome.

Draft Guide on Promos for Biologics/Biosimilars

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Federal Register notice: FDA makes available a draft guidance entitled Promotional Labeling and Advertising Considerations for Pre...