FDA Related News

Human Drugs

DeGette Wants FDA Drug Hoarding Action

Rep. Donna DeGette calls on FDA to take several steps to ensure that patients who need hydroxychloroquine and chloroquine for approved indications can...

Medical Devices

Medtronic Gets Ventilator EUA

Medtronic describes several actions to increase its manufacturing of ventilators to help patients hospitalized with Covid-19.

Human Drugs

FDA Watching Serological Tests for False Claims

FDA says it is concerned that some firms are falsely claiming that their serological tests are FDA approved/authorized or that they can diagnose Covid...

Human Drugs

Fast Track for Non-opioid Pain Drug

FDA grants EicOsis a Fast Track designation for its lead drug candidate, EC5026, for treating neuropathic pain.

Human Drugs

CARES Act OTC Monograph Provisions Explained

Hyman, Phelps & McNamara outlines key provisions in the OTC monograph reform provisions included in the coronavirus recovery legislation.

Medical Devices

Lawmakers Press FDA on Covid-19 Test Accuracy

Two House lawmakers ask FDA to provide information about Covid-19 test accuracy in the wake of testing failures earlier this year involving Centers fo...

Medical Devices

Stimulation Device Final Rule Delay Sought

The Judge Rotenberg Center asks FDA to delay indefinitely the effective dates for a final regulation banning the use of electrical stimulation devices...

Biologics

Pfizer, BioNTech Developing Covid-19 Vaccine

Pfizer and BioNTech say they are working together on clinical trials and manufacturing capacity for an mRNA Covid-19 vaccine.

Human Drugs

Seneca Gets FDA Guidance on Phase 3 Trial

Seneca Biopharma says FDA has provided significant guidance on the design of a Phase 3 trial for the companys neural stem therapy intended to treat AL...

Stakeholder Comments on Biologics Advertising Q&A

Stakeholders comment on an FDA draft guidance on promotional labeling and advertising considerations for biological reference products and biosimilars...