Pew: Restore FDA Oversight of Lab-developed Tests 04/29/2021

2 Bills Affecting FDA Signed Into Law 04/26/2021

FDA Should Require Better Cancer Drug Trial Representation: Study 04/29/2021

FDA/HHS Withdraw Trump Policy on Drug Stats 04/30/2021

7 Topics Discussed at MDUFA 5 Reauthorization Meeting 04/28/2021

2 Bills Introduced to Speed Generic Drugs 04/30/2021

Acceleron Failed to Submit Trial Results: FDA 04/28/2021

AdvaMedDx Comments on FDA Viral Mutation Impact Guidance 04/29/2021

Court Applies ‘Rule of Reason’ in ‘Pay-for-Delay’ Opana Case 04/27/2021

Quality in 510(k) Review Pilot Ending 04/27/2021

BsUFA Reauthorization Steering Committee Ground Rules Set 04/28/2021

Latest Federal Register Notices 05/02/2021

Since Our Last Issue ... 05/02/2021

Product Approval Summaries 05/02/2021

Pacific Medical Recalls Alaris Pump Front Bezel 04/30/2021

Leo Dermatitis Drug Gets ‘Complete Response’ 04/30/2021

Drugs Prices Higher in U.S. than 3 Other Countries: GAO 04/29/2021

FDA ‘Unable to Approve’ Tysabri sBLA 04/29/2021

FDA Addressing TIRF REMS Recertification Concerns 04/29/2021

Analysis Hits National Academy cBHT Report 04/28/2021

Panel Backs Keytruda and Tecentriq in Bladder Cancer 04/28/2021

Protalix Gets ‘Complete Response’ on Fabry Therapy 04/28/2021

Inspection Delay Impacts Sol-Gel NDA Review 04/27/2021

Antisense Oligonucleotide Nonclinical Testing Guidance 04/27/2021

Erica Jefferson Returning to FDA 04/27/2021

Latest FDA Warning Letters 04/27/2021

FDA Lifts Clinical Hold on Huntington’s Therapy 04/26/2021

Clinical Hold Lifted on UniQure Gene Therapy 04/26/2021

House Hearing on Lowering Rx Drug Prices 04/26/2021

Pharmacometric Models in Drug Development: FDA 04/26/2021