RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.
Regulatory Focus Articles RSS Feed 2.0
24 June 2021
The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.

Latest News

ALL
24 June 2021
Patients with incurable cancers should be included in clinical trials for investigational cancer therapies, regardless of whether they have received available treatments, the US Food and Drug Administration (FDA) recommends in a draft guidance rel...
24 June 2021
Updated 24 June to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Sinopharm and Bharat Biotech as well as on vaccine candidates from the Kazakhstan Research Institute for Biological Safety Problems and the Cuban ...
24 June 2021
Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence for some of these products and provide more gu...
24 June 2021
The European Council and Parliament have reached an informal deal on a planned health technology assessment (HTA) law. European Union officials are working on the HTA law to support cross-border cooperation on the clinical assessment of health tec...
23 June 2021
More than four years after the 21 st Century Cures Act was signed into law, Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on Tuesday circulated a discussion draft of their proposed Cures 2.0 legislation, setting the stage for negotiations ...
23 June 2021
“I think we have to think about a different kind of FDA if we're going to be well prepared to deal with the kinds of emerging science that we see today,” said Shuren. “It’s more than just having the enabling technologies for us to use. It will com...
23 June 2021
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
22 June 2021
Clinical trials for COVID-19 vaccines have so far “almost universally excluded” patients who are in active cancer treatment, to the detriment of the knowledge base about how the vaccine will work in people receiving these treatments, according to ...
22 June 2021
“Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK,” said William Maisel, director of the Office of Product Evaluation and Quality at ...
22 June 2021
China’s National Medical Products Administration (NMPA) has published its annual drug evaluation report for 2020. The report describes sharp increases in the number of applications processed by the regulator during the pandemic-affected year.