Biologics Archives - Lachman Consultant Services, Inc.

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

By Webmaster Lachman Sep 01, 2022 Biologics Compliance FDA Manufacturing

Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Porter 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 […]

May

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

By Bob Pollock May 09, 2022 Biologics Compliance FDA Legislation Medical Devices New Drugs Regulatory Affairs

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 […]

Feb

Second Covid-19 Vaccine Fully Approved January 31, 2022

By Bob Pollock Feb 01, 2022 Biologics BLA COVID-19 Regulatory Affairs

FDA took action to fully approve Moderna’s Spikevax which had been the subject of an Emergency Use Authorization (EUA) since December 18, 2020. This means that the FDA has finalized its comprehensive review of the safety and efficacy of the Moderna vaccine. This is the second Covid-19 vaccine to gain full BLA approval status, the […]

Dec

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

By Bob Pollock Dec 09, 2021 Biologics BLA CMC FDA

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 The FDA says, “This final guidance updates the draft guidance of […]

Nov

AAM GRx-Biosims Day 1 – Afternoon, Part II

By Bob Pollock Nov 09, 2021 Biologics Compliance FDA Generics Regulatory Affairs

The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage. The […]

Nov

AAM Meeting Day 1 – Afternoon, Part I

By Bob Pollock Nov 09, 2021 Biologics Compliance FDA Generics Regulatory Affairs

Since I am not a superhero and am unable to be in two places at once, I had to choose which of the afternoon sessions I would attend. With one of the hot topics being the inspectional issues raised by the COVID-19 pandemic, I chose to sit in on the Post-COVID Inspection World: New Tools, […]

Jul

Big Day in the Biosimilar World – First Interchangeable Product Approved for Insulin!

By Bob Pollock Jul 29, 2021 Biologics Biosimilars FDA Interchangeable biosimilars Regulatory Affairs

Everyone knew this day would come and it has been a long time in coming. Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product. An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider. According to the FDA announcement, “Semglee (insulin glargine-yfgn) […]

Feb

Staying Ahead of SARS-CoV-2 Variants as You Develop Your Monoclonal Antibody Products

By Keith Webber Feb 24, 2021 Biologics COVID-19 FDA Regulatory Affairs

As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals. Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population. The good news is that the FDA […]

Dec

FDA’s Adcom Meeting for Moderna COVID Vaccine

By Bob Pollock Dec 17, 2020 Biologics COVID-19 Vaccines

Today, December 17, 2020, the Vaccine and Related Biological Products Advisory Committee meeting discussed the Moderna vaccine. That vaccine is an mRNA vaccine, much the same as the Pfizer-BioNtech vaccine. To remind you, the mRNA vaccine: Does not replicate Does not enter or integrate into DNA And the Moderna vaccine does not contain any preservatives […]

Dec

NEWS FLASH – COVID-19 Vaccine Vote from the Advisory Committee Meeting

By Bob Pollock Dec 11, 2020 Biologics EUA FDA Regulatory Affairs Vaccines

Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine. I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study. […]

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Biologics