FDA Related News

Clarifications Sought in Transdermal, Topical Draft Guidance

Two companies ask FDA to clarify technical aspects of a draft guidance on the development of transdermal and topical delivery systems.

Medical Devices

QS Violations Found in Silfradent Inspection

FDA warns Italys Silfradent about QS and MDR violations in its manufacturing of the Surgybone medical device.

Human Drugs

KemPharm NDA for ADHD Prodrug

KemPharm files a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder.

Medical Devices

FDA/CDC Make More Respirators Available

FDA and the Centers for Disease Control and Prevention take action to make more respirators available to health care personnel because of the coronavi...

Medical Devices

FDA Sees SweynTooth Cybersecurity Vulnerabilities

FDA warns about the SweynTooth family of cybersecurity vulnerabilities.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Acino Products, Chemland, Jiangsu JDC Medical Devices and Silfradent.

Medical Devices

CPAPNEA Medical Supply Optipillows Violations

FDA warns CPAPNEA about multiple violations in its manufacturing of Optipillows.

Human Drugs

Name Covid-19-Related Drug Shortages: Public Citizen

Public Citizen calls on FDA and drug industry trade associations to publicly identify all drugs that are in shortage due to the Covid-19 epidemic.

Medical Devices

FDA Allows Broader Lab Testing as Virus Spreads

As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA implements a new policy to permit cer...

Federal Register

Neo Tect Kit Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that CIS Bio Internationals Neo Tect Kit was not withdrawn from sale for safety or effectiveness reasons.