This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.

In an untitled letter dated 19 January 2022, the US Food and Drug Administration@s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, the ...

Sprout Pharmaceuticals@ promotion of Addyi both mischaracterizes the drug@s indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US ...

340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...

The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency@s postmarket ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection (SSDC).

FDA also chastised the company for its failure to conduct stability testing program for its drug products in a timely manner. FDA said that “stability testing was overdue by 3 months or longer for a ...

The Central Drugs Standard Control Organization (CDSCO) has shared guidance on obtaining a certificate to export new drugs from India. @ ...

Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU Medical Device Regulation (EU MDR) submissions, but there is limited guidance on survey procedure ...

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2023 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and ...

The US Food and Drug Administration (FDA) on Friday approved the first new molecular entity as part of an international collaborative review effort dubbed Project Orbis.