ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register 72 (40) Docket 1999D-2013, relates to “cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act,” including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.
Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, the contract manufacturer, and the final-product manufacturer. Specifically, the draft guidance details the following:
Notification of any proposed change in the product, production process, quality controls or facilities
Notification of results of tests and investigations related to or impacting the product
Notification of products manufactured in a contract facility
Standard operating procedures.
The comment period for the draft guidance ends September 21, 2007.
Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics. The announcement, released in the Federal Register 72 (40) Docket 1999D-2013, relates to “cooperative manufacturing arrangements applicable to biological products licensure under section 351 of the US Public Health Service Act,” including short-supply, divided manufacturing, shared manufacturing, and contract manufacturing arrangements.
Primary topics covered in the document include reporting and recordkeeping responsibilities relating to these arrangements for the licensed manufacturer, the contract manufacturer, and the final-product manufacturer. Specifically, the draft guidance details the following:
The comment period for the draft guidance ends September 21, 2007.
Complying with European versus US GMPs
While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Quality, Resilience, and Reinvention in Pharma Manufacturing
The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Capsida Previews Its Oral and Poster Presentations for ASGCT 2025
The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.
CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.
Complying with European versus US GMPs
While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Quality, Resilience, and Reinvention in Pharma Manufacturing
The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Capsida Previews Its Oral and Poster Presentations for ASGCT 2025
The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.
CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.