FDA Related News

Federal Register

ANDA Pre-submission Facility Correspondence Draft Guide

Federal Register notice: FDA makes available a draft guidance on ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions.

Human Drugs

FDA Approves 2 Melinta NDAs for Antibiotic

FDA approves two Melinta Therapeutics NDAs for Baxdela (delafloxacin), indicated in adults for treating acute bacterial skin and skin structure infect...

Human Drugs

Complete Response Sent to Egalet On New Pain Drug Doses

FDA seeks more information from Egalet Corp. after sending a complete response letter on a prior approval supplement for Oxaydo (oxycodone HCl, USP) t...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes China Resources Zizhu Pharmaceutical and Sewaren Innovative Pharmaceutical Packaging.

Human Drugs

CGMP Violations at Qinhuangdao Zizhu

FDA warns Chinas Qinhuangdao Zizhu Pharmaceuticals about CGMP deviations in its production of active pharmaceutical ingredients.

Human Drugs

Compounding Violations at Sewaren Innovative

FDAs New Jersey District Office warns Sewaren Innovative about compounding drug violations in its production of sterile drugs.

Guidance on Electronic Signatures in Clinical Investigations

FDA issues a draft update to a 2003 guidance on electronic signatures in clinical investigations.

Medical Devices

Zimmer Biomet FDA-483 Response

FDA releases Zimmer Biomets 12/21/16 response to observations from an agency inspection at its Warsaw, Indiana, facility.

Medical Devices

FDA Clears Hologic Herpes Assay

FDA clears the Hologic Aptima HSV 1&2 assay.

Human Drugs

Gottlieb Pledges Revamp on Targeted Drug Development/Reviews

FDA commissioner Scott Gottlieb pledges during a congressional hearing to revamp the new drug development process for targeted drugs.