FDA Related News

Human Drugs

Bipartisan Draft Bill to Cut Health Costs

The Senate HELP Committee releases a draft of bipartisan legislation with more than 30 specific provisions for reducing health care costs, including s...

Medical Devices

FDA Approves Novocure Device for Mesothelioma

FDA approves a Novocure humanitarian use device for NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-...

Medical Devices

FDA Clears Modified Erbe Port Connector

FDA clears a modified Erbe Erbeflo 24-hour use endoscope port connector with a backflow prevention feature.

Medical Devices

Safety Alert on Beckman Coulter Hematology Analyzers

FDA issues a safety alert on a Class 1 recall of Beckman Coulters DxH 800, DxH 600 and DxH 900 hematology analyzers due to inaccurate blood platelet c...

FDA General

Subcommittee Advances FDA Budget Bill with $184 mil. Boost

A House Agriculture subcommittee votes to advance a fiscal year 2020 spending bill that would increase FDAs budget authority by 6% ($184 million) over...

Human Drugs

3 Observations from Lupin Inspection

FDA releases the FDA-483 with three observations following an inspection at Indias Lupin, Ltd., drug manufacturing firm.

Medical Devices

Roche Gains cobas TV/MG Test Clearance

FDA clears a Roche 510(k) for the cobas TV/MG test for use on the cobas 6800/8800 Systems for detecting Trichomonas vaginalis and Mycoplasma genitaliu...

Human Drugs

Comments on Bioavailability Studies Draft Guidance

Two drug industry stakeholders comment on an FDA draft guidance on bioavailability studies submitted in NDAs and INDs.

Human Drugs

Injunction Sought Against Supplement Company Over CGMPs

The Justice Department asks a federal court for an injunction to stop Confidence USA from selling dietary supplements that dont meet cGMP requirements...

80 FDA Regulations on Spring 2019 Unified Agenda

The governments Spring 2019 rule list includes 80 proposed rule stage and final rule stage items from FDA.