The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017
FDA Issues Draft Guidance on Size and Shape of Generic Tablets and Capsules
The draft guidance would apply to ANDAs and ANDA supplements for additional strengths. Unless there are safety issues, approved generic products would not be expected to change their characteristics to conform to the draft guidance, or to match changes in the RLD.
Comments are due by March 10, 2014, although FDA regulations permit comments on guidances to be submitted at any time. Manufacturers may want to comment on the appropriateness of the identified characteristics (perhaps there are others that FDA missed) or of the amount of variation presented as presumptively acceptable.
The author thanks Katelyn Ruiz for her assistance.
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