FDA Related News

Medical Devices

Singlera Genomics Colon Cancer Assay Pathway

Singlera Genomics says it has completed a pre-submission meeting with CDRHs Office of In Vitro Diagnostics and it was provided clear guidance on the r...

Federal Register

FDA Withdrawing 7 ANDA Approvals

Federal Register notice: FDA announces the approval withdrawal of seven ANDAs from multiple applicants after they notified the agency that the drug pr...

Federal Register

Covid-19 Guidance Availability and Requested Comments

Federal Register notice: FDA makes available guidance documents related to the coronavirus disease 2019 (Covid-19) public health emergency.

FDA General

Since Our Last Issue

Industry news you may have missed since our last issue.

Medical Devices

1st Saliva Home-collection Covid-19 Sample Authorized

FDA grants Rutgers Clinical Genomics Laboratory an emergency use authorization for the first diagnostic test with the option of using home-collected s...

Human Drugs

Drug Outsourcing Firm Cited After Inspection

FDA cites RC Outsourcing (Lowellville, OH) for GMP issues after the drug outsourcing facility was inspected in February.

Senators Question FDA Oversight on Covid-19 Products

Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) ask FDA how it is tracking the use, safety, and effectiveness of scores of products on the ma...

Federal Register

Guide on Drugs for Cytomegalovirus in Transplants

Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation.

Human Drugs

Over 1,000 Clinical Trials Halted Due to Covid-19

A German researcher says that over 1,000 clinical trials having been stopped due to restrictions brought on by the Covid-19 virus.

Medical Devices

FDA Posts Performance Data on Antibody Tests

FDA posts summarized performance data for 12 antibody (serology) tests that have been granted emergency use authorizations for detecting the bodys imm...