Prior Decisions Should Guide New Drug Reviews: Researchers 09/21/2021

CDC Backs Most of FDA EUA for Covid Booster 09/23/2021

AdvaMed Comments on FDA Device Remanufacturing Guidance 09/23/2021

MITA Concerns With FDA Remanufacturing Guidance 09/22/2021

Reverse CA Decision Punishing Scientific Speech: WLF 09/23/2021

FDA Goals for BsUFA 3 Released 09/22/2021

FDA Revises Authorizations of Some Covid Tests 09/23/2021

Court Nixes FDA Compounding MOU with States 09/22/2021

Workshop on Orthopedic Device-Related Infections 09/22/2021

Attorneys See Good Things in PDUFA 7 Goals 09/21/2021

Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA 09/23/2021

J&J Touts Vaccine Booster Data 09/21/2021

Since Our Last Issue ... 09/26/2021

Latest Federal Register Notices 09/26/2021

Product Approval Summaries 09/26/2021

FDA Extends Review of Pfizer Growth Hormone 09/24/2021

FDA Generic Drugs Office Modifies Scientific Priorities 09/24/2021

Cordis Recalls Angiographic Catheter 09/23/2021

Suspend Vitamin B6 Sales: Emery Pharma Petition 09/23/2021

10 Observations in Greenpark FDA-483 09/23/2021

CGMP, Other Violations at Furley Bioextracts 09/22/2021

4 FDA/ECRI Material Safety Summaries Out 09/22/2021

ICH Meeting on Continuous Manufacturing, Other Topics 09/21/2021

Panexcell, Synchron Studies Are ‘Unacceptable’: FDA 09/21/2021

Paige Prostate AI Software Marketing Authorization 09/21/2021

FDA Defers Action on Humira Biosimilar 09/21/2021

‘First’ Lucentis Biosimilar Approved by FDA 09/20/2021

Guide on Controlled Correspondence Related to Quality 09/20/2021

Medtronic Unit Recalls Brain Aneurysm Stents 09/20/2021

FDA Complete Response on Verrica NDA 09/20/2021