Biologics

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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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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03
Nov

Industry and Regulators Working to Prevent Drug Shortages

I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida.  The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations.  The conference was well attended by both industry and regulators. Although I found all of the […]

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03
Nov

Convergence and Collaboration Themes at 2022 ISPE Annual

At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]

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02
Nov

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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01
Sep

Lachman and Law Firm Arnold & Porter to Host Webinar on FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST. Cell and […]

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09
May
Law and justice concept

Is Help on the Way? Contrast Agents and Drug Device Conundrum May Be Legislated Away

In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal.  This court decision dealt with […]

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09
Dec

FDA Finalizes Guidance on Annual Reportable CMC Changes for Specified Biologic Products

In today’s Federal Register (here), the FDA announced the availability of a final guidance for chemistry manufacturing and control changes (CMC) that may be reported in an annual report (AR).  CMC changes that may be submitted in an annual report are considered minor changes.  The FDA says, “This final guidance updates the draft guidance of […]

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