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10
Mar
First Quarterly Reports for Competitive Generic Therapy Designation and Priority Review Applications - Lachman Blog

First Quarterly Reports for Competitive Generic Therapy Designation and Priority Review Applications Under Section 807 the Act

“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 designation under section 506H of the FD&C Act.” These […]

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06
Mar
Business meeting, high five and corporate team celebrate target, profit and success of development, marketing and teamwork. Diversity, management and happy, men and women support mission and vision

February 2025 OGD Unofficial Approval Totals and Projections from First Quarter Results

The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions.  For a month with only twenty-eight days and one federal holiday, the OGD’s approval-action total is not too bad.  Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think […]

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03
Mar
Official December 2024 OGD Stats Finally Out Along with New Mean and Median Approval Times - Lachman Blog

Official December 2024 OGD Stats Finally Out Along with New Mean and Median Approval Times

Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in […]

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27
Feb
Flu Vax AdCom Cancelled - Sends Shivers Down Health Care Professionals Necks - Lachman Blog

Flu Vax AdCom Cancelled – Sends Shivers Down Health Care Professionals Necks

Each year about this time the FDA sponsors an Advisory Committee meeting to flush out the best guesses of experts on what would be the best composition of next season’s flu vaccines. MSN reports (here), “[T]he annual meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is crucial for drugmakers to ensure […]

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26
Feb
Update on FY 2024 Suitability Petitions - Lachman Blog

Update on FY 2024 Suitability Petitions

As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six […]

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25
Feb
Is the Freeze Beginning to Thaw - Lachman Blog

Is the Freeze Beginning to Thaw?

There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]

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24
Feb
Healthy Food Labeling Delayed Until April 28 2025 - Lachman Blog

Healthy Food Labeling Delayed Until April 28, 2025

According to one of the few Federal Register (FR) notices we have seen relating to FDA activities, today’s pre-publication page of the FR notes that “[i]n accordance with the memorandum of January 20, 2025, from the President, entitled ‘Regulatory Freeze Pending Review,’ the effective date of the final rule entitled ‘Food Labeling: Nutrient Content Claims; Definition […]

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