FDA Related News

Federal Register

Pilot Program on Pharmaceutical Supply Chain Security

Federal Register notice: FDA announces a pilot project program under the Drug Supply Chain Security Act to assist in developing an electronic, interop...

Federal Register

Comments Sought on Animal Drug User Fee Waivers

Federal Register notice: FDA seeks comments on an information collection extension for a guidance on Animal Drug User Fees and Fee Waivers and Reducti...

Human Drugs

Cures Act MCM Provisions Outlined

FDA explains 21st Century Cures Act provisions affecting development of medical countermeasure products.

Human Drugs

Gottlieb Tells More on on Generic Drug Policy Relief

FDA commissioner Scott Gottlieb outlines new approaches the agency will implement to help speed up generic drug reviews and approvals during an openin...

Federal Register

Comments Sought on ICH Clinical Practice Guide

Federal Register notice: FDA seeks comments on a new information collection associated with Guidance on E6 (R2) Good Clinical Practice; International ...

Federal Register

Comments Sought on DTC Studies

Federal Register notice: FDA seeks comments on proposed studies on Character Space-Limited Online Prescription Drug Communications.

Groups Still Oppose Intended Use Final Rule

Three industry trade associations reiterate their reasons for opposing an FDA final rule on how a medical products intended use will be determined for...

Human Drugs

Extended Use Date on Another Pfizer Product

FDA adds another Hospira drug to the list of those with extended use dates in response to a recall of drugs in shortage.

Medical Devices

FDA OKs Biotroniks Intica DX Defibrillator

FDA approves Biotroniks Intica DX cardiac resynchronization therapy and implantable cardioverter defibrillator system.

FDA General

Flat FDA Budget Moves Through Senate Subcommittee

The Senate Agriculture Appropriations Subcommittee approves $2.8 billion in discretionary funding for FDA for fiscal year 2018, which is $1 million ov...