FDA Official Lists Four Regulatory Considerations For Connected Combination Products (MedtechInsight)
Pear Therapeutics undergoes another round of layoffs, cutting 22% of staff (MedtechDive)
ResMed, Google sibling Verily form digital health venture to improve access to sleep treatment (MedtechDive)
UK Has ‘Much Room For Improvement’ On Genomic Testing Access (MedtechInsight)
Government, Regulatory & Legal
The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
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The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
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.