FDA Intelligence | FDA

Advertising and Promotion

Jul 6, 2019
OPDP Enforcement Emphasizing Risk Minimization
Jun 8, 2019
Recent Untitled Letter Offers Blueprint for…
May 6, 2019
Consumer Education Needed on DTC Ad Info
Apr 6, 2019
New Era of Drug Promotion Dawns
Mar 11, 2019
Gottlieb Will Be a Tough Act To Follow
Nov 27, 2018
NEJM Perspective Article Questions DTC Pricing…
Nov 12, 2018
‘Bad Ad’ Program Is Alive and Well
Oct 24, 2018
What Companies Can Do About Competitor’s ‘Bad Ads’
Sep 11, 2018
Fundamental Change May Be Coming for Direct-to-…
Jul 14, 2018
OPDP Enforcement Picks Up

Good Clinical Practice

Nov 15, 2018
Don’t Overlook Institutional Conflicts of Interest
Oct 30, 2018
Targeting Trial Recruitment Ads Can Be Tricky
May 2, 2018
Investigator Brochures in Early Trials Found…
May 2, 2018
Audit Finds Non-Profits Fall Short on Trial…
Dec 8, 2017
More Transparency Needed in Nutrition Research
Nov 27, 2017
Practice of Excluding Prior Cancer Survivors from…
Sep 15, 2017
NIH Releases Tools To Aid Researchers in…
Aug 23, 2017
Number of FDA BIMO Inspections Drop Nearly 10…
Aug 18, 2017
IRBs Need To Rethink Payments to Research Subjects

Food Labeling

Sep 18, 2017
CFSAN Wants Ideas on Reducing Regulatory Burdens
Sep 18, 2017
FDA Allows First Qualified Health Claim To…
Aug 15, 2017
Rulemakings on Bioengineered Food, Revision of…

FDA Regulation & Enforcement

Sep 10, 2018
FDA Releases CDER Inspection Scheduling Policy,…
Sep 7, 2017
CDER Review Staff To Work with ORA in New Team-…
Aug 29, 2017
FDA Seizure, Warning Letter Signal New…
Jul 5, 2017
FDA To Delay Enforcement of DSCSA Drug Product…

Medical Devices

May 2, 2018
Redesign, Recall, FDA Communication Address…
May 2, 2018
FDA Safety Action Plan Promises Increased Focus…
Sep 13, 2017
CDRH Explores Streamlined Review of PMA…
Aug 1, 2017
FDA Launches Program for Precertifying Software…
Jul 25, 2017
CDRH Announces Voluntary Pilot Program for…

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