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FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Research on Assessing Terms Used in Drug Promotion

Federal Register notice: FDA sends to OMB a proposed information collection entitled Assessment of Terms and Phrases Commonly Used in Prescription Dru...

Federal Register

Study on Medical Conference Drug Promoton

Federal Register notice: FDA seeks comments on a proposed study entitled Medical Conference Attendees Observations About Prescription Drug Promotion....

Federal Register

Survey on Drug Facility Risk Management

Federal Register notice: FDA seeks comments on a proposed Survey of Drug Product Manufacturing, Processing and Packing Facilities 21 CFR parts 210 an...

Medical Devices

410 Medical Gains Expanded Use for LifeFlow

FDA clears a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previous clearances for c...

Human Drugs

FDA Makes Changes to Drug Name Program

FDA makes modernized changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agencys software tool for determining orthographic...

FDA General

House Panel Denounces Trump Block on Hahn Testimony

House Energy and Commerce Committee leadership denounces the White House after it blocked FDA commissioner Stephen Hahn from testifying before the Com...

Human Drugs

Medimetriks Cutting Phase 3 Enrollment After FDA Meeting

Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to mode...

Human Drugs

Junshi Bio Orphan Status for Soft Tissue Sarcoma

FDA grants Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma.

Marketing

OPDP Looking at Medical Conference Drug Promotion

The CDER Office of Prescription Drug Promotion says it wants to ask medical conference healthcare professional attendees about their experiences at dr...