FDA Related News

Human Drugs

Torrent Pharma Expands Losartan Recall

Torrent Pharmaceuticals expands its recall from 10 lots of losartan potassium tablets to include six lots of losartan potassium and hydrochlorothiazid...

Medical Devices

Rebound Therapeutics Aurora Surgiscope Cleared

FDA clears a Rebound Therapeutics 510(k) for the Aurora Surgiscope System, a single-use disposable neurosurgical endoscope for minimally invasive acce...

Human Drugs

FDA Accepts 2 Merck sNDAs for HIV Drugs

FDA has accepted for review two Merck supplemental NDAs for HIV-treating drugs Pifeltro (doravirine, 100 mg) and Delstrigo (doravirine 100 mg, lamivud...

FDA General

50 Health Groups Protest Shutdowns Impact on FDA

Some 50 healthcare-related associations ask the president and Congress to end the government shutdown and bring FDA back to full capacity.

Medical Devices

Protein Product Immunogenicity Testing Guidance Out

FDA issues a guidance to help industry facilitate development and validation of assays to assess immunogenicity of therapeutic protein products during...

Human Drugs

FDA Denies Petition on Oral Health Drug Monographs

FDA denies an American Dental Association petition asking that the agency open rulemaking to revise five oral health OTC drug product monographs.

PhRMA Spent $27.5 Million on Lobbying in 2018

Bloomberg News says that drug company and trade association lobbying expenses hit new highs in 2018.

Medical Devices

AI Benefits, Challenges in Decision Support Software

The Duke-Margolis Center for Health Policy examines artificial intelligence-enabled clinical decision software and FDAs regulatory role.

Medical Devices

Imperative Care Neurovascular Access Catheters Cleared

FDA clears an Imperative Care 510(k) for its line of neurovascular access catheters, which are intended to deliver interventional treatments during ne...

Human Drugs

Senate Hearing to Tackle Drug Pricing

The Senate Finance Committee plans a 1/29 hearing on Drug Pricing in America: A Prescription for Change, Part I.