Drug and Device Digest – A Weekly Digest of Drug and Device FDA News

A Weekly Digest of Drug and Device FDA News

This digest is a TL;DR version of current FDA-regulated Drug and Device news

FDA Briefs: CDER, CDRH news
Link and Learn: FDA initiatives
Other: R&D information, FDA Meeting Debriefs

For FDA sponsored Public Meetings: Drugs, Devices, Advisory Committees

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Recent Posts

December 9, 2018 Drug & Device Advisory Group FDA Briefs

FDA News & Views: Real-World Evidence framework, Women’s Health Research roadmap, Clinical Testing advances, Human Genetic Variant databases, De Novo pathway improvement, Collaborative Community toolkit, Opioid Use Disorder challenge, Blood Glucose Monitors safety/accuracy, Patient Engagement Advisory Committee

November 28, 2018 Drug & Device Advisory Group FDA Briefs

FDA Market Authorizations: AEMCOLO for travelers’ diarrhea, YULPERI for COPD, GAMIFANT for rare immune disease, DAURISMO for AML

November 26, 2018 Drug & Device Advisory Group FDA Briefs

FDA News and Views: Transforming 510(k) Program, Increased Medical Device Inspections, Social Media Trends for Drug Use, Drug Use Software, Addressing Drug Shortages, Waiver or Alteration of Informed Consent

November 19, 2018 Drug & Device Advisory Group FDA Briefs

FDA Market Authorization: ADCETRIS for peripheral T-cell lymphoma, DPP Ebola Test, picoAMH Test for Menopause, INNOVO electrical stimulatory for incontinence

November 15, 2018 Drug & Device Advisory Group FDA Briefs

FDA News & Views: MyStudies App, Asthma and OTC Treatment, Improving Expanded Access, Modernizing Sterile Drug Inspections