RAPS Highlights

 

 

 

 

03 February 2023 | By Joanne S. Eglovitch
EMA wants participants to serve on clinical trial multistakeholder forum

The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for r...

03 February 2023 | By Ferdous Al-Faruque
This Week at FDA: Restructuring at inspections office, new guidances and staff, 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...

02 February 2023 | By Joanne S. Eglovitch
FDA draft guidance addresses clinical development of drugs to treat early Lyme disease

The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors de...

02 February 2023 | By Ferdous Al-Faruque
Shuren: FDA needs new authorities to prevent device shortages beyond public health emergencies

The head of the US Food and Drug Administration’s (FDA) device center says he will continue to work with Congress and the medtech in...

02 February 2023 | By Joanne S. Eglovitch
Recon: US FDA gives thumbs up to GSK anemia drug; Vax makers kept $1.4 billion in COVID shot prepayments

COVID-19 tracker: Merck pill linked to new mutations, study says  FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COV...