Guideline News
EU Authority writes to MA holder with regards to Azido impurity in irbesartan
Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has written to a marketing...
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USFDA publishes guidance for Bispecific Antibody Development Programs
U.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides...
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Pharmeuropa publish revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles
A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition...
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US FDA issues guidance for ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
On May 19, 2021, the FDA finalized the guidance for industry entitled “ANDAs for Certain Highly...
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FDA Issues Final Guidance on Demonstrating Bioequivalence for Soluble Powder Animal Drugs
On May 20, 2021, the FDA issued final guidance for industry (GFI) #171 entitled “Demonstrating Bioequivalence...
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US FDA updates Q & A guidance on Inspections During COVID-19
FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the...
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IMWP monographs on Favipiravir and on Favipiravir tablets published
The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert...
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Revised monograph Water for injections published for public comment in Pharmeuropa
The revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2),...
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US FDA publishes final guidance on ICH Q12
U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12...
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FDA publishes final guidance for BCS Based Biowaivers
On May 11, 2021, the FDA published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based...
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