FDA Related News

Medical Devices

FDA Lifts, Then Dashes LASIK Patients Hopes

After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH lifts their hopes for...

Federal Register

Docket Number Corrected on Post-approval Changes Guide

Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approval Changes to Drug Su...

Human Drugs

3 Drug Product Identifier Guidances

FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product identifiers.

FDA General

DoJ Argues Against APA Rules Challenges

Attorney Anne Walsh says the Justice Department has directed its civil litigators to oppose court attempts to impose nationwide injections, including ...

Human Drugs

Impurity Acceptance Criteria MAPP

CDER issues a Manual of Policies and Procedures on establishing drug substance and drug product impurity acceptance criteria for NDAs, ANDAs, and BLAs...

Human Drugs

Arca Biopharma Seeks Special Protocol for Heart Failure Trial

Arca Biopharma submits a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride...

Biologics

FDA Rejects Pharming Expanded Use for Ruconest

FDA issues a Pharming Group complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current ...

Medical Devices

Ways to Improve Pediatric Device Development: AdvaMed

AdvaMed gives FDA recommendations for ways to reduce risk in pediatric medical device development.

Medical Devices

Olympus 510(k) for EZ Shot 3 Plus Needle Cleared

FDA clears an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine ne...

CTTI Releases Real-World Evidence Meeting Summary

The Clinical Trials Transformation Initiative reports on its public meeting on best practices and needed resources for advancing use of real-world evi...