RA/QA News Roll: May 2023

Here's what's happening at FDA and across the broader life science RA/QA space.

We occasionally post a roll-up of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news as well as the stories, research, and insights that might be harder to find.

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Here are some industry happenings from the past few weeks.

FDA Guidances

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• The FDA has issued new guidance for the testing of glycerin and other chemicals used in drug manufacturing. The 11-page guidance highlights the health hazards associated with contaminants diethylene glycol and ethylene glycol, emphasizing the need for immediate implementation. The FDA has received reports of fatal poisonings linked to DEG and EG, particularly in cough and allergy products, resulting in over 300 deaths, mostly among children under the age of five. The guidance stresses the importance of thorough testing and awareness of the supply chain for high-risk components. Manufacturers, suppliers, and pharmacies are urged to comply with the guidelines to ensure product safety. The FDA's actions come after recent warning letters and import halts issued to foreign drugmakers due to concerns of contamination with DEG and EG. (FDA / fda.gov)

• The FDA has released draft guidance proposing recommendations for decentralized clinical trials of drugs, biologics, and medical devices. DCTs involve conducting trial activities outside traditional clinical trial sites, utilizing telehealth visits and local healthcare facilities. The guidance aims to advance medical product development, increase participant diversity, and reduce barriers to participation. It covers design considerations, remote visits, digital health technology usage, sponsor and investigator roles, informed consent, and monitoring. The FDA acknowledges the flexibility of fully decentralized or hybrid trials and emphasizes the need for planning and coordination. Public comments on the draft guidance are welcomed until August 1, 2023, and the FDA plans to collaborate with sponsors to implement decentralized components into trials.