USA – FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against...
Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently...
USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of...
Canada – Notice – Implementation of ICH E19: A selective approach to safety data...
Health Canada, as an official member to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to...
USA – FDA releases FY 2022 generic drug research summary
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year...
USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential...
USA – Uptake of biosimilars on the rise in the US, but number of...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...
USA – FDA Says Face-to-Face Meetings Include Virtual
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled...
USA – FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
The investigation was prompted by preliminary data from the CDC’s vaccine safety monitoring system, which raised a question of whether people aged 65 years...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
