Regulatory Affairs

06
Dec

November Is “Unofficially” in the Books – OGD Approval Numbers Await Official Publication

Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers.  At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]

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29
Nov

Where Have All the Official Stats Gone, Long Time Passing!

The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance.  The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]

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29
Nov

Accelerated Approvals – Here Is One to Watch

It is always interesting to see how the Agency works when one action could trigger another action.  In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]

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28
Nov

Holidays Got You Sufferin’ – Need Some Bufferin – Not to Worry!

The November 23, 2022 issue of the Federal Register (here) contained a Proposal To Withdraw Approval of a New Drug Application for Bufferin (Aspirin) Tablets (NDA 006499) originally approved June 30, 1948 thought to still be held by Bristol Myers.  The Agency proposed to withdrawal this NDA for failure to submit required annual reports.  It […]

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22
Nov

Bulk Drugs for Use in Compounding by 503B Compounders – Score: +2, -3

Outsourcing compounding facilities are those that register with the FDA as such under section 503B of the Federal Food Drug and Cosmetic Act.  According to the FDA, “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is […]

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17
Nov

FDA Provides Thanksgiving Gift of 49 New and Revised Product Specific Guidances (PSGs)

In its never-ending quest to provide timely guidance on bioequivalence requirements for generic versions of brand name products, today, the FDA published 29 new and 20 revised BE guidance recommendations in the pre-publication of Federal Register Notice (here) as well as on their website (here, hint: look for the newly added and revised links on […]

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15
Nov

OTC Naloxone Coming Down the Road?  FDA Would Like to Think So!

The opioid/fentanyl crisis, along with the abuse of other opioid‑based products, has put the prospect of an over‑the‑counter (OTC) version of naloxone high on the FDA’s priority list.  Making the product available in a ready and easy‑to‑use format (for instance, a nasal spray or autoinjector) would increase the availability of this potentially life‑saving drug.  Now, […]

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15
Nov

OGD Extolls Review Enhancement at GRx+Biosims Meeting

At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes.  He outlined a number of these changes from GDUFA II […]

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