The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

Marketing 40

Marketing Production Radiology Cosmetics 40

pharmaphorum

OCTOBER 4, 2022

Part 2 of this series is devoted to clinical decision support (CDS) software. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The final guidance follows the draft CDS software guidance issued on the same date in 2019.

Development 104

Development Regulation Cosmetics Life Science 104

The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices in the Center for Devices and Radiological Health.

Marketing 52

Marketing Clinical Trials Clinical Trials Radiology 52