FDA Related News

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...

Medical Devices

FDA Wants RWD User Fee Funding Comments

FDA solicits stakeholder views on external organizations that could receive real-world data funding from MDUFA 5.

Biologics

Janssen Ending Mosaico HIV Vaccine Trial

Janssen says it will discontinue its Mosaico Phase 3 trial of an HIV vaccine after a data review showed the vaccine was not effective.

Human Drugs

Deny Mifepristone Preliminary Injunction: FDA

FDA asks a Texas federal court to reject an Association for Hippocratic Medicine request for a preliminary injunction to overturn the agencys approval...

Biologics

Moderna to Seek RSV Vaccine OK

Moderna says it will seek regulatory approval for an investigational mRNA RSV vaccine for use in older adults.

Human Drugs

SFJ Pharma BLA for Blood Thinner Reversal Agent

SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals, and it is planning to fil...

Human Drugs

Improve HHS Oversight of Pathogen Research: GAO

The Government Accountability Office says HHS could improve its oversight of research involving enhanced potential pandemic pathogens.

Human Drugs

CDER Continuing QMM Program Development

The CDER Office of Pharmaceutical Quality says its two Quality Management Maturity pilots provided insights into how better to develop and implement a...