FDA Related News

Human Drugs

CGMP Deviations at Mexican Signa Facility

FDA warns Canadas Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.

Centurion Medical Products Kit Issues

FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile convenience kits.

Federal Register

Meeting on User Fee FDA-Sponsor Communications

Federal Register notice: FDA announces an 8/11 public meeting entitled Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices i...

Federal Register

FDA Panel to Review Mesoblast BLA

Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemcel-L for acute graft-...

Human Drugs

Pieris Pharma Study of Cancer Drug on Hold

FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an additional in-use and ...

Federal Register

FDA Withdraws Approval of 10 ANDAs

Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...

Federal Register

Draft Guide on Appealing Mammography Actions

Federal Register notice: FDA makes available a draft guidance entitled Appeal Options Available to Mammography Facilities Concerning Adverse Accredita...

Human Drugs

Cannabis Research Quality Guidance

FDA issues a draft guidance on quality considerations for clinical research related to developing drugs containing cannabis or cannabis-related compou...

Human Drugs

New COA Grant Funding Opportunity

FDA offers a second funding opportunity to develop core sets of clinical outcome assessments for four areas.

Biologics

FDA Not Cutting Vaccine Standards: Companies

Drug company executives try to reassure a House committee that FDA will not lower its standards to approve a Covid-19 vaccine.