FDA Related News

Federal Register

Device Shortages Information Collection

Federal Register notice: FDA sends to OMB an information collection revision on Shortages Data Collections.

FDA Reviews South Koreas Covid-19 Actions

FDA reports on South Koreas actions to combat Covid-19, particularly involving diagnostic tests.

Federal Register

Guide on Pediatric Studies in Cancer Drugs

Federal Register notice: FDA makes available a final guidance on molecularly targeted oncology drug pediatric studies.

Human Drugs

FDA Mostly Positive on Teplizumab

FDA says Provention Bios teplizumab was successful in a submitted BLA trial in delaying the onset of Type 1 diabetes in at-risk patients.

Medical Devices

ChoiceSpine 510(k) for Cervical Spacer System

FDA clears a ChoiceSpine 510(k) for the Blackhawk Ti Cervical Spacer System.

Human Drugs

10 Observations in Hospira FDA-483

FDA releases an FDA-483 with 10 observations from an inspection at a Hospira sterile drug manufacturing facility.

Animal Drugs

FDA Animal Antibiotic Concept Paper Substantially Flawed: Pew

The Pew Charitable Trusts says an FDA concept paper on the duration of use of medically important antibiotic drugs used in or on animal feed needs sig...

Human Drugs

Keep Drug Companies Outside Clinical Trial Networks: Woodcock

FDA acting commissioner Janet Woodcock calls for greater independence from drug companies in the nations clinical trial processes and procedures.

Federal Register

Vaccines Panel to Discuss Pediatric Covid Vaccines

Federal Register notice: FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid19 pediatric vaccine...

Federal Register

Panel to Review FibroGen Anemia Drug

Federal Register notice: FDA announces a 7/15 Cardiovascular and Renal Drugs Advisory Committee meeting to review FibroGen anemia drug for use in kidn...