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The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.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 Specifically, the draft guidance details the following: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The comment period for the draft guidance ends September 21, 2007.
Comment Period Open on Draft Guidance on Cooperative Manufacturing for Biologics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The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?
Rockville, MD (July 23)-The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, Cooperative Manufacturing Arrangements for Licensed Biologics.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 Specifically, the draft guidance details the following:
The comment period for the draft guidance ends September 21, 2007.
Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances
The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.
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 Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
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.
Latigo Biotherapeutics Raises $150 Million to Advance Non-Opioid Pain Therapeutics
With financing led by Blue Owl Capital, Latigo will use the funds to further develop non-opioid pain treatments as well as develop other candidates in its pipeline.
DCAT Week 2025: Sustainability in Medical Propellants
PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.
Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin, Other Drug Substances
The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.
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 Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy
Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.
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.
Latigo Biotherapeutics Raises $150 Million to Advance Non-Opioid Pain Therapeutics
With financing led by Blue Owl Capital, Latigo will use the funds to further develop non-opioid pain treatments as well as develop other candidates in its pipeline.
DCAT Week 2025: Sustainability in Medical Propellants
PharmTech Group chatted with Markus Laubscher of Orbia during DCAT Week 2025, covering the topics of sustainability, regulatory hurdles, next-generation innovation, and the DCAT Week experience.