FDA Related News

Human Drugs

Haemonetics Recalls 18 Acrodose Lots

FDA says Haemonetics is recalling 18 lots of Acrodose Plus and PL systems due to report of low pH readings for platelets in some lots.

Medical Devices

Draft Guide on Expanded Abbreviated 510(k) Program

Federal Register notice: FDA makes available a draft guidance entitled Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivale...

Medical Devices

2 New Genetic Disease-Based Test Guidances

FDA issues two final guidances to aid development of next generation sequencing-based diagnostic tests.

$2.4 Billion in Health Care Fraud Judgments, Settlements

HHS and the Justice Department issue a report on the FY 2017 healthcare fraud and abuse control program.

Human Drugs

Novartis Afinitor Disperz Approved for Certain Seizures

FDA approves a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients...

Human Drugs

Collegium Wants Oxycodone ER Restrictions

Collegium Pharmaceutical asks FDA to reject NDAs for extended-release oxycodone products that dont meet requirements the company wants to have specifi...

Federal Register

Consumer Reps Sought for Advisory Committees

Federal Register notice: FDA seeks the participation of consumer organizations in the selection of voting and nonvoting consumer representatives to se...

Human Drugs

13 Observations in Alkem FDA-483

FDA issues an FDA-483 with 13 observations from an inspection at Indias Alkem Laboratories.

Medical Devices

Performance Criteria for 510(k) Equivalence

FDA publishes an overview guidance on using performance criteria under the expanded abbreviated 510(k) program.

Human Drugs

AbbVie Elagolix NDA Review Extended 3 Months

FDA extends by three months its review of an AbbVie NDA for elagolix in endometriosis-associated pain to review additional information related to the ...