FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

USA – FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures...
EMA takes note of the European Ombudsman’s decision on pre-submission activities

Europe – EMA takes note of the European Ombudsman’s decision on pre-submission activities

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further...
MHRA launches consultation on how to best engage patients and the public

UK – MHRA launches consultation on how to best engage patients and the public

The responses will help inform the MHRA’s future engagement with patients and the public. The MHRA wants to adopt a more systematic approach to listening...
FDA Discusses RWD, RWE With Industry, Academia

USA – FDA Discusses RWD, RWE With Industry, Academia

Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and...
Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France

Europe – Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines...

La Banque européenne d'investissement (BEI) et la société pharmaceutique Advicenne ont signé un accord de prêt de 20 millions d'euros, soutenu par le Fonds...
FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

USA – FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH)...
Updated Fundamentals of US Regulatory Affairs Book

USA – Updated Fundamentals of US Regulatory Affairs Book

RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the most extensive regulatory affairs textbook available, covering US regulations for...
NICE U-turn for Kisqali in breast cancer

UK – NICE U-turn for Kisqali in breast cancer

The decision comes just three months after the governing body issued a draft guidance rejecting the drug, citing that “it is not known whether...
Indian drugmakers form partnerships as they enter the Chinese market

India – Indian drugmakers form partnerships as they enter the Chinese market

Indian drug makers Sun Pharmaceutical Industriesand Cipla are entering China through local partnerships, as they seek new markets to sell their generic drugs amid stifling competition in...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...

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