RAPS Highlights

 

 

 

 

09 August 2022 | By Ferdous Al-Faruque
FDA issues Jynneos EUA to stretch monkeypox vaccine supply

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordics’ monkeypox vaccine Jynne...

09 August 2022 | By Joanne S. Eglovitch
Drugmakers request changes to FDA’s mass balance studies guidance

The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mas...

09 August 2022 | By Ferdous Al-Faruque
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation

When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy ...

09 August 2022 | By Nick Paul Taylor
Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct

Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as ...

09 August 2022 | By Joanne S. Eglovitch
Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal

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