cmc requirements for combination products

cmc requirements for combination products

Doug Mead, Sr. Director, CMC RA, Devices and Combination Products, Janssen Research & Development, LLC March 26, 2019 Disclosures: •The following presentation includes the personal views of the presenter and do not necessarily represent the official views of Janssen R&D, LLC. CMC Requirements for an Investigational New Drug Application (IND) Eldon E. Leutzinger, Ph.D. Office of New Drug Quality Assessment 1 CDER / FDA Two TopicImaging Workshop: Manufacturing of Positron Emission Tomography (PET) Radiopharmaceutical Products April 14, 2010 Natcher Conference Center, NIH, Bethesda, MD where active substances are included in separate pharmaceutical forms marketed i n the same package. (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional ™ . As a result, we guarantee a flatness of 1/4 ASTM A6 on TruSHIELD 500 plate products .300” and thinner. Learn about our TruFLAT technology here. Disclaimer ... • Facilitate understanding of issues and regulatory requirements to bring innovative products and processes to market: •ATMPs, stratified medicines, nanomedicines, advanced The purpose of the FDA gene therapy guidances is to inform sponsors how to provide sufficient CMC information for gene therapy and combination products. CMC Impact Metals sets the standard for flatness on light gauge quenched and tempered products with our state-of-the-art process. • 21 CFR 4 - Current Good Manufacturing Practice Requirements for Combination Products – For single-entity CPs containing a biologic and a device both the biologic cGMP and Device QSR regulations apply. How to Prepare a … Controls (CMC) in a New Drug Application (NDA)-14-Apr-2010 1 PET Drug Products-Ravindra K Kasliwal, Ph.D. Office of New Drug Quality Assessment Center for Drug Evaluation and Research U.S. Food and Drug Administration Device Combination Products in the EU Janine Jamieson , MHRA, UK May 2016. The development of medical devices and combination products that contain a device constituent is a regulated activity. combination medicinal products containing three or more active substances. • Applies to all combination products. The Chemistry, Manufacturing & Controls (CMC) Certified Professional (CMCCP) Chemistry Certification program will benefit those involved in the development and manufacture of pharmaceuticals, as well as, those preparing CMC documents for submission to regulatory agencies. Biotechnology-Derived Products” (1995) – “Formal MeetingsBetween the FDA and Sponsors or Applicants” (2009) CMC/GMP Related FDA Guidances Applicants (2009) – “IND Meetings for Human Drugs and Biologics - Chemistry, Manufacturing, and Controls Information” (2001) – “INDs for Phase 2 and Phase 3Studies - Chemistry, Market research firms continue to forecast that the drug-led combination marketplace will continue on a path of growth and expansion, increasing the importance for pharmaceutical and biotechnology companies to have clearer understanding of regulatory requirements for combination products. CMC Requirements for a Phase 1 In general, Phase 1 studies are closely monitored and meant to introduce a new drug into human subjects. Current Good Manufacturing Practice Requirements for Combination Products (1/2017) • The cGMP requirements that apply to each of the constituent parts apply to the combination product they constitute. – Drug-drug compatibility for combination products » Compatible Actives – can mix active ingredients into one formulation, if desired » Non-compatible Actives – may need to keep active ingredients physically separated to minimize reactions, e.g., bilayer tablets – Compatibility of active ingredient(s) with excipients • Excipients The guideline does not address the requirements for combination packs, i.e. For Phase 1 studies, the main focus of the required CMC information is safety from the perspective of the risk to the patient.

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