FDA Related News

Biologics

Vaccine Electronic Safety Report Info

FDA posts online information for vaccine manufacturers to submit safety reports electronically to CBER.

Medical Devices

Armis Biopharmas Toe Implant Approved

FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction p...

Biologics

Regenerative Cell Institute Illegally Marketing Cellular Products: FDA

FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.

Medical Devices

FDA Clears EOGas 4 Ethylene Oxide Gas Sterilizer

FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and co...

Human Drugs

FDA Approves Modified Definity for Echocardiograms

FDA approves a Lantheus Holdings/Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid microsphere) injectable su...

Human Drugs

Pfizer/BioNTech Filing Covid Vaccine EUA in Days

Pfizer and BioNTech plan to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final anal...

Federal Register

Info Collection on Expedited Drug Programs

Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biolo...

Federal Register

Drug Compounding Registration Info Collection

Federal Register notice: FDA sends to OMB an information collection revision related to the registration of human drug compounding outsourcing facilit...

HHS Speaker Program Fraud Alert

The HHS Inspector General says drug and device companies and healthcare professionals should weigh the risks when considering whether to participate i...

Federal Register

NDA Withdrawal Notice Corrected

Federal Register notice: FDA corrects a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple...