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Human Drugs

CalciMedica Advancing Covid-19 Drug Trial

CalciMedica says it is transitioning an ongoing randomized open-label study to a blinded placebo-controlled trial for Auxora (in patients with Covid-1...

Human Drugs

Trump Wants Drug Pricing Bill, Grassley Says

Sen. Chuck Grassley says President Trump said at a Republican senatorial luncheon that he still wants to see drug pricing legislation passed by Congre...

Human Drugs

FDA Improving (Q)SAR Models

FDA says that drug developers are interested in applying (quantitative) structure-activity relationship models that have been improved by agency resea...

Medical Devices

Covid PMA or HDE Supplement Guidance

FDA issues an immediately-in-effect guidance to help address manufacturing limitations or supply chain issues arising from the Covid-19 public health ...

Medical Devices

FDA Posts List of Removed Antibody Tests

FDA releases a list of antibody tests that the agency expects will not be marketed or distributed for several reasons.

Human Drugs

FDA Sentinel Collaboration on Covid Drugs

The FDA Sentinel Operations Center at the Harvard Pilgrim Health Care Institute is working with TriNetX on projects to assess usage of medications use...

Human Drugs

Biota Biosciences Recall 3 Drug Products

Biota Biosciences recalls five lots of Cannabidiol Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they were marketed withou...

Stericycle Predicts Surge in FDA Enforcement After Pandemic

Stericycle says medical device and drug manufacturers should expect a significant uptake in FDA regulatory and enforcement action once the nation move...

Human Drugs

Comments on Liquid Drug Flow Restrictor Guidance

Four stakeholders give FDA recommendations for changes to a draft guidance on flow restrictors for oral liquid drug products.

Federal Register

Arthritis Advisory Panel Renewal

Federal Register notice: FDA announces the renewal of the Arthritis Advisory Committee for an additional two years beyond the charter expiration date.