RAPS Highlights

 

 

 

 

31 March 2023 | By Ferdous Al-Faruque
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions

The US Food and Drug Administration (FDA) published a draft guidance outlining how sponsors of artificial intelligence and machine l...

31 March 2023 | By Michael Mezher
This Week at FDA: Califf’s budget testimony, ISO IDMP guidance, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device...

30 March 2023 | By Ferdous Al-Faruque
US lawmakers again propose diagnostics reform bill

US House lawmakers have re-introduced a bill that would give the Food and Drug Administration (FDA) explicit authority to regulate c...

30 March 2023 | By Nick Paul Taylor
Euro Roundup: EU answers questions about extension of MDR transition, removal of ‘sell off’ periods

Across the 10-page text, the Commission answers 18 questions about the applicability of the revised transitional period to custom-ma...

30 March 2023 | By Joanne S. Eglovitch
EMA’s quality innovation group helps to propel regulatory path for novel technologies

BASEL, Switzerland – The European Medicines Agency’s (EMA) newly formed Quality Innovation Group (QIG) aims to clarify regulatory ex...