RAPS Highlights

 

 

 

 

29 November 2022 | By Joanne S. Eglovitch
FDA warns Illinois eye clinic for conducting study without IND

The US Food and Drug Administration (FDA) recently warned a clinical trial sponsor for failing to submit an investigational new drug...

29 November 2022 | By Ferdous Al-Faruque
Industry groups challenge FDA’s LASIK guidance, call for withdrawal

Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on lase...

29 November 2022 | By Mary Ellen Schneider
Industry groups seek changes to nonprescription drug access proposal

Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requi...

29 November 2022 | By Joanne S. Eglovitch
Recon: Second patient death linked to Alzheimer’s drug lecanemab rocks Eisai, Biogen; Roche withdraws Tecentriq’s bladder cancer indication

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

29 November 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: Singapore’s HSA finalizes LDT guidelines

The 22-page guidelines feature examples of test systems that do and do not meet the definition of LDT. HSA does not classify researc...