FDA Related News

Medical Devices

510(k) Refuse to Accept Policy Guidance

FDA issues a guidance explaining its process for accepting and reviewing 510(k) submissions.

Medical Devices

New Device Human Subject Protection Rule Now in Effect

FDA reminds stakeholders that 2/21 is the effective date for compliance with the final rule on Human Subject Protection; Acceptance of Data from Clini...

Medical Devices

Agfa Multipurpose Imaging System Cleared

FDA clears an Agfa 510(k) for the DR 800 multipurpose imaging system with tomosynthesis.

FDA Antimicrobial Susceptibility Test Guidance Explained

CDRH staffer Ribbi Shawar describes changes between the draft and final versions of a new guidance on coordinated development of antimicrobial drugs a...

Human Drugs

CGMP Violations at Hangzhou Sunking Nonwovens

FDA warns Chinas Hangzhou Sunking Nonwovens about CGMP violations in its manufacturing of finished pharmaceuticals.

Human Drugs

API Deviations in Vipor Chemicals Inspection

FDA warns Indias Vipor Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Human Drugs

Xencor Leukemia Study Placed on Partial Hold by FDA

FDA places a partial clinical hold on a Xencor a Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients wi...

Medical Devices

Pre-Cert Working Model 1.0 Discussed

In a CDRH Webinar, associate director for digital health Bakul Patel explains the latest updates to the Centers pre-certification pilot program.

Federal Register

Class 2 for Titration Devices for Oral Appliances

Federal Register notice: FDA classifies auto titration devices for oral appliances into Class 2 (special controls).

Human Drugs

Mercks Keytruda Approved for Melanoma

FDA approves Mercks Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete r...