27
Jul
Stack of one hundred dollars notes on dollars background

New GDUFA Fees for FY 2024

On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024.  Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita.  Generic […]

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26
Jul

Braille or No Braille, That Was the Question! Now We Have the Answer!

Back on January 30, 2023,  I wrote a blog (here)  concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug.  In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]

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21
Jul

Mother Nature Just Can’t Cut the Drug Industry a Break

With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States.  Ed Silverman, of the publication STAT, reports  that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]

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12
Jul
Pediatric Exclusivity List - Lachman Consultants

Pediatric Exclusivity List Updated – Not Much Activity??

As we know, many drug products are approved initially only for adult patients. The Pediatric Research Equity Act (PREA) of 2003 “gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for […]

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07
Jul

Unofficial ANDA Approval Actions for June 2023

Another bit of good news for generic approvals!  June unofficially recorded seventy‑five full‑approval actions and thirteen tentative‑approval actions for a total of eighty‑eight approval actions for the month.  The seventy‑five full approvals represent the second highest number of full‑approval actions in a month thus far this FY, with the big daddy still being March with […]

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05
Jul

May 2023 Official Statistics Are in The Books

Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong.  In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions.  Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle.  […]

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21
Jun

Unofficial Mid-June 2023 ANDA Approval Tally

Well, June got off to a rousing start!  In the first fifteen days, the OGD issued forty‑six full‑approval actions and nine tentative‑approval actions.  This represents one of the best mid‑month totals (fifty‑five) that we’ve seen in a long time.  If the month continues at this pace, we’re likely to see over 100 approval actions for […]

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15
Jun

A New MaPP and a Lot of Red Tape?

A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests.  A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally.  In this case, it describes how the FDA will adjudicate a request to […]

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