New Drugs

08
Dec

FDA Proposes Rule to Change the IND Annual Report

Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]

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11
Nov

Nitrosamines – Where Are We Now?

Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned?  That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference.  The session devoted […]

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09
Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

Is a mature pharmaceutical quality system really a competitive advantage?  The industry held this as a belief, but progress in a tangible program was always elusive.  On  November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]

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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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02
Nov
CrossRoad

Oncology Drugs and Cross Labeling – An Important Document – But Hurdles May Still Exist

Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens (https://www.fda.gov/media/162806/download) that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use.  As I read the guidance a few things popped into my mind. How can one firm who owns […]

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06
Oct

Most User Fees for FY 2023 Appear on Federal Register Pre-Publication Page Today – But a Glitch with GDUFA Fees?

The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022.  However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]

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09
Sep

After ADCOM’s Favorable Nod for ALS Drug, Will Another Shoe Drop? Just Saying!

With the demise of the Alzheimer’s drug aducanumab after the FDA’s accelerated approval and CMS’s actions to raise Medicare premiums in anticipation of huge demands based on its proposed pricing, we may now face another similar situation and that is with a drug for amyotrophic lateral sclerosis (ALS).  After a 7-2 favorable vote by the […]

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08
Sep

 OTC Statement of Identity Advice Given in FDA Guidance

The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products.  The guidance notes that “[T]he […]

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01
Sep

Still Slugging Away at Opioid Abuse and Overdose,  FDA Presents Yet Another Revised Plan

The nation has been struggling with drug abuse for as long as I can remember.  The current opioid crisis keeps the problem on the front page, especially with fentanyl being disguised in a drug of abuse which has become one of the most deadly drugs of abuse in the long war on drugs. FDA has […]

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