FDA Related News

Human Drugs

Product-Specific Estring BE Guidance Needed: Pfizer

Pfizer asks FDA for a product-specific guidance on demonstrating bioequivalence to its Estring vaginal ring.

Biologics

FDA Says Organogenesis Owes a Gintuit Pediatric Study

FDA says that Organogenesis has not submitted a required pediatric study for its Gintuit allogenic oral soft tissue product.

Human Drugs

Odefsey Labeling Changes Approved

FDA approves changes to labeling for Gileads Odefsey to add 48-week data from trials in which subjects switched to Odefsey from either Complera or Atr...

Human Drugs

FDA Nixes Data Package on Cardiome NDA Proposed Resubmission

FDA tells Cardiome Pharma that a data package proposed by the company would not be sufficient to support a resubmission of its NDA for Brinavess(verna...

Federal Register

Docket Established for DTC Risk Info Recommendations

Federal Register notice: FDA establishes a public docket to assist with its development of recommendations on the communication of risk information in...

Human Drugs

Facility Information Pre-Submission Guidance Being Revised

FDA says it will revise a draft guidance on submission of facility information for expedited priority ANDA reviews in response to changes in the lates...

Medical Devices

FDA Adds Medical Device Cybersecurity Standard

FDA recognizes UL 2900-1 as a medical device cybersecurity standard.

Medical Devices

FDA Public Meeting on Pediatric Big Data

FDAs Office of Pediatric Therapeutics announces a 9/18-19 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEPT): Applic...

Stakeholders Support Records Guidance

Stakeholders offer support for an FDA draft guidance on electronic records and signatures, with recommendations to improve it.

Federal Register

CDRH Mailing Address Change for Device Classifications

Federal Register final rule technical amendment: FDA is amending the Medical Device Classification Procedures regulation to reflect a change in addres...