FDA Related News

Federal Register

Briviact Injection/Solution Regulatory Review Period

Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact oral solution and separately for a...

Medical Devices

Cochlear Osia 2 Hearing Implant Cleared

FDA clears a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant.

Marketing

Vivitrol Ad Omits Risk Information: OPDP

The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk information.

Human Drugs

Xolair sBLA for Treating Nasal Polyps

FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not respond well to intr...

Human Drugs

OTC Drug Reform Passes Senate

The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.

Human Drugs

Panel Rejects Correvios Vernakalant Over Safety

FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for use to rapidly conv...

Medical Devices

Sozo Cleared for Assessing Protein Calorie Malnutrition

FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.

FDA General

Courts Could See FDA Warning Letter as Final Action

Attorney Michelle Yeary says a DC federal court decision might open the way for FDA Warning Letters to be considered final agency action.

Human Drugs

CRN Praises Court Decision in Fish Oil Case

The Council for Responsible Nutrition praises the Supreme Courts refusal to hear an Amrin appeal of a fish oil dietary supplement case.

Alert on Recalled Products from Basic Reset/Biogenyx

FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx, have been recalled.