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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03
Nov

Face-to-Face Meetings – FDA Clarifies the Term

So, you have just been granted a face-to-face (FTF) meeting with the FDA.  Woohoo!  You’re going to Bethesda!  Don’t be too quick to make those plane and hotel reservations.  This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes […]

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03
Nov

Activities Report of the Generic Drugs Program – GDUFA II Quarterly Performance

As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”.  The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news.  First, the number of ANDA awaiting FDA action […]

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