Generics

29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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22
Jun
FDA Updates

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved.  The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]

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18
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

ERRATA for JUNE 16, 2020 POST* – OGD Updates April 2020 Stats and Reports Official May 2020 Approvals, CRLs, and New ANDA Receipts

The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month).  OGD also acknowledged 65 new ANDAs in April. Of the […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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11
Jun

Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement

Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA).  The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]

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03
Jun
New and Revised Bio Guidances Issued by OGD Image

New and Revised Product Specific Bioequivalence Recommendations List Update

The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations.  FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]

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