NYT to FDA: Abolish 510(k), Fix other Device Loopholes 05/06/2019

U.S. Drug Supply is ‘Best Ever:’ CDER 05/10/2019

TV Ad Drug Price Rule Finalized 05/08/2019

SCOTUS Decision Could Increase False Claims Cases: Report 05/09/2019

Drug, Medical Device Recalls Down 05/07/2019

Real-World Evidence Submission Guidance 05/08/2019

J&J Settles Metal Hip Cases for $1 Billion 05/08/2019

House Passes 2 Bills on Orange and Purple Books 05/08/2019

Oncology Drug Reproductive Toxicity Testing Guidance 05/09/2019

Comments on Nonproprietary Biologic Naming 05/08/2019

DTC Accelerated Approval Disclosure Study 05/07/2019

Companies Using Drug Development AI: Tufts Survey 05/07/2019

Latest Federal Register Notices 05/12/2019

Product Approval Summaries 05/12/2019

Since Our Last Issue ... 05/12/2019

Medical Device Safety Act Reintroduced 05/10/2019

Biosimilar Interchangeability Final Guidance 05/10/2019

PhRMA Wants Combination Product Guidance Clarified 05/09/2019

ICH Guideline for Clinical Study Considerations 05/09/2019

Abandon FDA Biologic Naming Plan: FTC 05/09/2019

Maximal Usage Trial Monograph Guidance 05/09/2019

ANDA vs. 505(b)(2) Determination Guidance 05/09/2019

FDA Draft Guidances on Drugs in Pregnancy, Lactation 05/08/2019

FDA Releases Immunomedics EIR 05/08/2019

FDA Weighing Certification of AI Devices That Learn: Report 05/07/2019

Torrent Pharmaceuticals FDA-483 Out 05/07/2019

Latest FDA Warning Letter 05/07/2019

CGMP Issues in Laboratoires Clarins Inspection 05/07/2019

Alert on Medtronic Pacemakers Due to Battery Drainage 05/07/2019

Guidance on Device Q-Submission Program 05/06/2019