FDA Related News

Human Drugs

Committee Backs Parateks Omadacycline

The FDA Antimicrobial Drug Advisory Committee tells the agency that Parateks omadacycline is safe and effective for two indications.

Federal Register

4 NDA Approvals Withdrawn by FDA

Federal Register notice: FDA withdraws approval of four NDAs from multiple applicants after they told the agency that the products were no longer mark...

Human Drugs

Guide on Drug Product Elemental Impurities

Federal Register notice: FDA makes available a final guidance entitled Elemental Impurities in Drug Products.

Drug Recalls Dropped in 2nd Quarter

Stericycle says that in the second quarter of this year drug recalls dropped and medical device recalls increased.

Human Drugs

Insys Therapeutics Agrees to $150 Million Fine with DoJ

Insys Therapeutics reaches an agreement in principle with the Department of Justice to pay $150 million to settle a civil and criminal investigation i...

Medical Devices

FDA Clears iCADs Latest Breast Density Software

FDA clears an iCAD 510(k) for its latest artificial intelligence software solution PowerLook Density Assessment Version 3.4 for breast density.

Human Drugs

AstraZeneca Settles Texas Medicaid Suits for $110 Million

Texas attorney general Ken Paxton says AstraZeneca will pay the state $110 million to settle suits over fraudulent Medicaid marketing of its Seroquel ...

Human Drugs

Dissolution Testing and Acceptance Criteria Guidance

FDA issues a guidance with recommendations for submission of NDAs, INDs, or ANDAs for orally administered immediate-release drug products containing h...

Human Drugs

FDA Approves First CGT Generic Drugs

FDA uses the Competitive Generic Therapy pathway to approve several strengths of Apotex potassium chloride solution.

Medical Devices

Rupture of Membranes Tests Have Limits: FDA

FDA cautions healthcare professionals not to rely on rupture of membranes tests alone and instead use them as part of a broader clinical assessment.