FDA Related News

Human Drugs

FDA Seeks Injunction Against LGM Pharma

FDA asks a Florida federal court for an injunction against LGM Pharma to ensure that it no longer holds and ships adulterated drugs.

Human Drugs

11 Observations on Intas Pharmaceuticals FDA-483

FDA releases the form FDA-483 with 11 observations from an inspection at Indias Intas Pharmaceuticals.

Medical Devices

Realize Medical Virtual Reality Surgical Tool Cleared

FDA clears a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning.

Fix the Evidence Generation System Now: Califf

FDA commissioner Robert Califf says FDA has a key role to play in reshaping the nations system for generating medical evidence to support new treatmen...

Biologics

Lilly Alzheimers BLA Rejected by FDA

FDA sends Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating early symptomatic Alz...

Medical Devices

Info Collection on Device Adverse Event Program

Federal Register notice: FDA seeks comments on an information collection extension entitled Adverse Event Program for Medical Devices (Medical Product...

Federal Register

Info Collection on Informed Consent, IRB Role

Federal Register notice: FDA sends to OMB an information collection extension entitled Protection of Human Subjects; Informed Consent; and Institution...

Mend Lax Clinical Trial Reporting: Pallone

Rep. Frank Pallone asks FDA and NIH what they are doing to enforce compliance with ClinicalTrials.gov reporting requirements.

Human Drugs

FDA Denies Fresenius Glycopyrrolate Petition

FDA denies Fresenius Kabis request that its glycopyrrolate solution receive a therapeutic equivalent rating with Hikmas Robinul.

Human Drugs

Contrast Agent, Radioactive Drug, OTC Drug Status Clarified

Attorneys James Bolani and Bonnie Odom discuss a Consolidated Appropriations Act provision that clarifies the regulatory status of contrast agents, ra...