FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|January 29, 2013
Regulatory Roundup for the Week of January 28, 2013
Author(s)Pharmaceutical Technology Editors
EMA announces collaboration with Israel, and USP updates chapter on elemental impurities.
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- ISPE has
updated its ISPE GAMP guidance on testing of GXP systems to help companies efficiently test computerized and software-based systems.
- France has
asked the European Medicines Agency (EMA) to review third- and fourth-generation combined oral contraceptives to determine if these drugs should be restricted to women who cannot take other combined oral contraceptives. The agency’s Pharmacovigilance Risk Assessment Committee will review the drugs and give its opinion and determine if a EU-wide recommendation is necessary.
- EMA has published
guidance on preparing and reviewing product characteristic summaries. The guidance outlines the European Commission’s principles on product characteristic summaries.
- EMA
announced an agreement for collaboration with Israel on industrial standards. The agreement includes “the mutual recognition of the conclusions of GMP inspections, of manufacturing and import authorizations, and of certification of conformity of each batch without rechecking at import.”
- The United States Pharmacopeial Convention (USP) has posted a
revision bulletin on <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures.
- FDA has
announced its Vaccines and Related Biological Products Advisory Committee Meeting will be held on Feb. 27, 2013. FDA is accepting public participation in the way of written submissions to be made on or before Feb. 20 and oral presentations that can be scheduled for Feb. 27, 2013.
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Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
FDA final guidance defines when companion app output counts as drug labeling and when device-connected or standalone apps belong in prescribing information.
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Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
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