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Human Drugs

Guidance on GDUFA Division Reconsideration Requests

FDA releases a draft guidance on the procedures for ANDA applicants to resolve scientific or regulatory disputes with FDA at the agency division level...

Human Drugs

Baxter Importing IV Drugs from Ireland

FDA says it is working with Baxter Healthcare to temporarily import some IV products manufactured at Baxters plant in Ireland to address shortages cau...

Human Drugs

Draft REMS Document Format Guidance Out

FDA publishes a draft guidance on the content and format of REMS documents, revising a 2009 draft guidance.

FDA General

Gottlieb Wants to Stay at FDA

FDA commissioner Scott Gottlieb says he believes he can most effectively serve the Trump administration as FDA commissioner rather than as HHS secreta...

Human Drugs

Janssen Files NDA for Prostate Cancer Drug

Janssen Biotech files an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castrat...

Medical Devices

Philips to Halt Defibrillator Manufacturing Under Consent Decree

Philips North America agrees to a consent decree with FDA that will see the company suspending external defibrillator manufacturing at its Andover, MA...

Human Drugs

CMC Guidance Clarifications Sought

Stakeholders ask for additional clarification and changes in an FDA draft guidance on CMC postapproval manufacturing changes for specified biological ...

Human Drugs

Opioid Abuse Study Contracts Awarded

CDERs Judy Staffa says the agency has awarded two contracts to organizations to help it better determine how well abuse-deterrent opioids are preventi...

FDA General

Malin Appoints von Eschenbach as Chief Medical Adviser

Malin Corp. appoints former FDA commissioner Andrew von Eschenbach as the companys chief medical advisor.

Human Drugs

Draft Guide on Developing RSV Drugs

FDA posts a draft guidance of Respiratory Syncytial Virus (RSV) Infection: Developing Antiviral Drugs for Prophylaxis and Treatment that addresses the...