31
Jan

FY 2022 GDUFA Science and Research Report – Impressive Findings and Conclusions

If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into.  The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for […]

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20
Jan

Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]

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19
Jan

Mid-January Peek at ANDA Approval Actions

With just about half of the month gone, and given that there have already been two holidays in January, the reported number of full-approval and tentative-approval actions looks pretty promising.  Through January 17th at 9 a.m. Eastern time, the OGD has listed twenty-eight full-approval actions and ten tentative-approval actions in the All Approvals database for a total […]

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13
Jan

Dear World, Ethylene Glycol Is Not a Sweetener and Is Poisonous Even as a Contaminant!

The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children.  In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections.  The problem with the drug was that it was very bitter, and, because of this, children […]

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16
Dec

New Reporting Structure and Metrics for OGD Statistical Reports

Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report.  The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report.  We will […]

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08
Dec

FDA Proposes Rule to Change the IND Annual Report

Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]

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08
Nov

GDUFA III Raises Hopes for Surprise PSG Issuance or Revision

GDUFA III Raises Hopes for Surprise PSG Issuance/Revision Explained at AAM’s GRx-Biosims Conference The product specific guidance (PSG) has been a big help to industry in outlining the requirements for establishing bioequivalence requirements for generic drug products.  OGD has issued over 2000 PSGs since the practice began.  While this has been a big boon to […]

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