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Medical Devices

Amalgam Concerns Flood Patient Info Docket

Patients and consumers worried about dental amalgams mercury content and its risks flood an FDA docket seeking input on Patient Preference Information...

Federal Register

Testing for Biotin Interference in IVDS

Federal Register notice: FDA makes available a draft guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.

Human Drugs

Drug Firms Sue to Stop Drug Prices in DTC Ads

Merck, Eli Lilly and Amgen sue HHS to block a rule that would require drug prices be included in direct-to-consumer ads.

Federal Register

FDA Withdraws 12 No-longer Marketed ANDAs

Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...

Federal Register

FDA Seeks Advisory Panel Consumer Reps

Federal Register notice: FDA requests that any consumer organizations interested in participating in selecting voting or nonvoting consumer representa...

Federal Register

Lumateperone Tosylate NDA for Schizophrenia to Panel

Federal Register notice: FDA announces a 7/31 Psychopharmacologic Drugs Advisory Committee meeting to discuss an Intra-Cellular Therapies schizophreni...

Human Drugs

FDA Orders Seizure of Life Rising Supplements

At FDAs request, U.S. marshals seize more than 300,000 dietary supplement containers, including tablets, capsules, and teas from Life Rising Corp.

Medical Devices

Diagnostic Device Biotin Interference Guidance

Following adverse events, including one death. and incorrect results, FDA publishes a draft guidance on biotin testing in in vitro diagnostic tests.

Human Drugs

FDA Supply Chain Blockchain Pilot

FDA selects four companies to participate in a drug supply chain blockchain pilot project.

Federal Register

Arthritis Advisory Committee to Review Ofev sNDA

Federal Register notice: FDA announces a 7/25 Arthritis Advisory Committee meeting to discuss a Boehringer Ingelheim supplemental NDA for Ofev (ninted...