22
Jan

MEDICAL DEVICE WEEK – A LACHMAN LEARNING EXPERIENCE – FEATURES WEBINAR ON FDA QUALITY INCENTIVE PROGRAMS

The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) […]

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12
Jan
How did that happen?

So Now We Know Why the OMUFA User Fee Notice Was Withdrawn

The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]

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22
Dec
CHANGES AHEAD: Roadside sign: Trailer mobile warning sign parked by road with words for safety by orange cones

Important – Facility Inspection Impact on Applications, Amendments, Resubmissions and Supplements

FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic.  While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections.  Because of this issue and the Agency’s goal of being transparent, they […]

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05
Nov
Drawing of a happy smiling emoticon on a yellow paper and white background.

October 2020 Best Month in Last Eighteen for Generic Approvals

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months.  That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions.  Why do […]

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28
Sep
Youth League Batter

Watch the Inventory of CRLs in Your Court – Don’t be Blindsided, Be Mindful

Did you ever wonder about the FDA’s requirement than an applicant respond to a complete response letter (CRL) within one year of its issuance as provided for in the regulations at 21 CFR 314.110?  Under this regulation, “an applicant must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified […]

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17
Sep
Surprised employer holding long resume, amazed with impressive career achievements

Official August 2020 Approvals and Receipts for ANDAs Reported

The Office of Generic Drugs (OGD) reported some of its official statistics for August today.  As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]

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02
Sep
Bumpy Road

Is the Orange Book Patent Listing Process becoming “Divisive”?

The Drug Price Competition and Patent Term Restoration Act of 1984 (better know as Hatch-Waxman) provided a balance between innovation and competition by permitting generic drugs to rely on the safety and efficacy of a previously approved reference listed drug (RLD) rather than unnecessarily repeating duplicative clinical testing to prove what was already known about […]

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01
Sep
Slippery Slope road sign in front of cloudy sky background

EUA for Vaccine – Slippery Slope or a Shot in the Dark

The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests.  By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]

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