Regulatory Affairs Professionals Society (RAPS)

TORONTO @ Medical product sponsors should consider clinical trial diversity plans as not only a regulatory requirement but also a marketing opportunity because they will give companies data that is more representative of their patients, according to Michelle Tarver, who was recently named director of the US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH).

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, FDA named the new permanent director of its medical device center, House Republicans published a report criticizing the Biden administration@s promotion of COVID-19 vaccines, and a much-anticipated draft guidance on communicating scientific information about unapproved uses of drugs is a step closer to being finalized.

Understanding radiological health devices has never been more vital for professionals in the industry.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: USHow a Donald Trump presidency would change health care, from Medicaid to the CDC (STAT)Feud between Prime and Tessera, two gene-editing companies, spills out into public (STAT)A drug may cause problems with chemotherapies in cancer patients with obesity. Many doctors are in the dark (STAT)

The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines to transition their products to the new regulations.

The European Commission@s Medical Device Coordination Group (MDCG) has issued guidance on how the medtech industry should handle ethylene oxide (EtO) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The sterilizing gas is widely used by the medtech industry to clean products, largely due to its ability to penetrate small spaces.

BARCELONA @ Manufacturers should ensure that their clinical evaluations for high-risk devices include a clear statement of the device@s benefit and a well-developed postmarket surveillance plan to ensure smooth notified body review of their submissions, asserted Susan Partridge, clinical regulatory lead at BSI, at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 23 October. @

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. There’s a lot to unpack from the past week – the election of Donald Trump to serve a second term as president has massive implications for both FDA and the regulated industry, though despite some incendiary comments about what’s to come, much remains to be seen about how the incoming administration will act.

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Merz Pharmaceuticals concerning a recent paid Instagram post promoting its Botox competitor Xeomin (incobotulinumtoxinA).

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, multiple outlets reported that Martin “Marty” Makary, a surgeon at Johns Hopkins Hospital and an outspoken and sometimes contrarian critic of public health measures – including vaccine mandates during the COVID-19 pandemic – is President-elect Donald Trump’s top choice to lead FDA.