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Device Trials and Patient Engagement Guide

[ Price : $8.95]

FDA posts a draft guidance on patient engagement in medical device clinical trials.

Guide on Moving Animal Antimicrobials to Rx-only

[ Price : $8.95]

FDA posts a draft guidance for industry on recommendations for changing medically important animal antimicrobial drugs from over-t...

Bill Seeks to Make Pediatric Vouchers Permanent

[ Price : $8.95]

Bipartisan House members introduce the Creating Hope Reauthorization Act to make permanent a priority review voucher program for p...

CDRH Health of Women Program Strategic Plan

[ Price : $8.95]

CDRH seeks comments on a just-released Health of Women Program Strategic Plan that aims to explore the unique issues related to th...

Guide on Drug Wholesaler Return Product Distribution

[ Price : $8.95]

FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product C...

2 Lots of Quinacrine Dihydrochloride API Recalled

[ Price : $8.95]

Darmerica recalls two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient due to a label mix-up.

Comments Sought on Developing CNS Stimulants

[ Price : $8.95]

Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous syste...

Device Guidances Under Safety/Performance Pathway

[ Price : $8.95]

Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency device Safety and Per...

Pilot on Device Conformity Assessment Program

[ Price : $8.95]

FDA releases a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, pr...

Novo Nordisk GLP-1 Approved for Diabetes

[ Price : $8.95]

FDA approves Novo Nordisks Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 dia...