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The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.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 Specifically, the draft guidance details the following: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The comment period for the draft guidance ends September 21, 2007.
Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics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The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.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 Specifically, the draft guidance details the following:
The comment period for the draft guidance ends September 21, 2007.
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Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.
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.
FDA Refines Regulatory Pathway for Canadian Drug Importation
FDA announced efforts to streamline its drug importation process to help U.S. states and Native American tribes access lower-cost Canadian drugs while maintaining safety standards.
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.
IND Application Cleared for Phase II Trial of Grifols’ Dry Eye Disease Drops
Grifols received FDA clearance to begin a Phase II trial of GRF312, an immunoglobulin eye drop for dry eye disease, aiming to improve current treatments.
CellCentric Completes $120 Million Series C Funding Round for Multiple Myeloma Treatment Inobrodib
Inobrodib is being developed as a first-in-class oral cancer drug that the company says will be able to treat not only multiple myeloma, but other specific cancers as well.