USA – Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
USA – FDA officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
USA – Global regulators discuss how they are adapting to AI, real-world data in...
Regulators across the globe have been preparing for the arrival of new artificial intelligence (AI) technologies and advances in real-world data (RWD) they say...
Europe – ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) convened on 6 and 7 December in Amsterdam the first meeting...
USA – FDA issues final rule on ‘right to try’ reporting requirements
Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
UK – Kidney Research UK concerned by NICE process
Kidney Research UK has responded to the National Institute for Health and Care Excellence (NICE) draft guidance on therapeutics for patients with COVID-19.
It follows...
International – WHO seeks to align biowaiver policy with ICH guidelines
The World Health Organization (WHO) wants to align its bioequivalence classifications with other global guidelines by reducing the number of in vivo studies required to prove...
