Regulation (EU) No 536/2014, known as the Clinical Trial Regulation (CTR), comes into effect in the...
Read moreThe EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a reflection paper which contains...
Read moreU.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance...
Read moreThe Food and Drug Administration is announcing the availability of a draft guidance for industry entitled...
Read moreFDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section...
Read moreCo-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has written to a marketing...
Read moreU.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides...
Read moreA new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition...
Read moreOn May 19, 2021, the FDA finalized the guidance for industry entitled “ANDAs for Certain Highly...
Read moreOn May 20, 2021, the FDA issued final guidance for industry (GFI) #171 entitled “Demonstrating Bioequivalence...
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