FDA Related News

Human Drugs

Dr Retter CGMP Violations Cited

FDA warns Mazowieckie, Poland-based Dr Retter Ec Wladyslaw Retter about CGMP violations in its production of over-the-counter drugs.

Medical Devices

Comments on Computational Modeling Guidance

Three stakeholders submit general and specific comments on an FDA computational modeling and simulation draft guidance.

Human Drugs

ViiVs Cabenuva Approved for HIV-1 in Adolescents

FDA approves ViiV Healthcares Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in certain virologically suppressed adolescents.

Medical Devices

Biobeat 510(k) for Expanded Wearable Patient Monitor

FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in addition to cuffless...

Stakeholders Comment on Digital Data Acquisition Draft

Stakeholders give comments and suggestions to FDA on its draft guidance on using digital health technologies for remote data acquisition.

Medical Devices

Comments on FDA Device Transition Guidance

Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 public health emergenc...

Human Drugs

FDA Approves Higher Dose of Ozempic Diabetes Drug

FDA approves a 2 mg dosage level of Novo Nordisks diabetes drug Ozempic.

Human Drugs

FDA Questions Modest Benefit in ALS Drug

An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data contained in Amylyx ...

Federal Register

Device Rule Reduces Paper Copy Submissions

Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the number of copies of cer...

Federal Register

Animal Drug Regs Amended for Approvals

Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbrev...