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August 16, 2022
GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...
August 15, 2022
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and...
August 12, 2022
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
August 10, 2022
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
August 8, 2022
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
August 5, 2022
Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...
August 4, 2022
National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The U.S....
August 3, 2022
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...
August 2, 2022
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...