FDA

#ICYMI: Join FDA for the hybrid 2024 Compounding Quality Center of Excellence Annual Conference on August 21-23, with a pre-conference session on August 19, to learn and build networks to help the industry improve the quality of compounded drugs for patients who need them. Learn more and register today: https://lnkd.in/eFYYDYDD

FDA issued the revised final guidance, "Container Closure System and Component Changes: Glass Vials and Stoppers." This guidance provides drug manufacturers with recommendations on reporting and implementation of some common changes to container closure system components consisting of glass vials and stoppers: https://lnkd.in/gYZn7jHa Today’s guidance supersedes the guidance initially issued in March 2021 titled “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers.” FDA revised and issued today’s final guidance because many of the recommendations set forth in the 2021 guidance are applicable outside the context of the COVID-19 public health emergency. In preparing this final guidance, FDA considered comments received on the 2021 guidance.

SAVE THE DATE: We’re hosting a “Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A” on Aug. 7, 2024. Join us from 2-3 p.m. (ET) to learn more about bioburden, bacterial endotoxin, and packaging integrity testing for sterile medical devices. Learn more: https://lnkd.in/eEb-RCCr

Today, FDA issued a final guidance describing the electronic over-the-counter (OTC) monograph submission requirements and providing recommendations and other information on how to send OTC monograph submissions to FDA in electronic format: https://lnkd.in/egTChfBD OTC monograph submissions must be submitted electronically, and, depending on the type of submission, should be submitted to FDA through the CDER NextGen Portal (https://lnkd.in/g93n52cN), or as specified by the instructions in the OTC Monographs@FDA portal (https://dps.fda.gov/omuf). Submissions related to updating drug listing information should be electronically submitted consistent with the Electronic Drug Registration and Listing System process and instructions.

CBER invites you to submit a #Proposal to the #RareDisease Endpoint Advancement (RDEA) Pilot Program, a collaborative initiative with @FDA_Drug_Info. Join us in advancing development of #RareDiseaseTherapies. Submit your proposal now! bit.ly/48UBUx4 #AcceptingProposals

FDA issued a Federal Register notice that establishes a public docket seeking substantive comments from interested parties on evaluating the immunogenicity risk of host cell proteins. For the purposes of this request, FDA is specifically interested in comments on suitable methods to detect, identify and control host cell proteins in commercial lots of recombinant peptide products (including information on achievable residual amounts of host cell proteins in the drug product) as well as in vitro, in silico immunogenicity assessment (IVISIA) of host cell proteins in recombinant peptide products: https://lnkd.in/gbGxJe_B FDA welcomes your comments to the public docket (Docket No. FDA-2024-N-2980) starting tomorrow until September 23, 2024. Additional details on how to comment can be found at the Federal Register notice.

Lights! Camera! Apply!! https://lnkd.in/epqWu4jS

Explore our new a webpage dedicated exclusively to monitoring the research on #microplastics and #nanoplastics in the food supply, what is known about the health effects and how we are working to advance analysis of scientific testing methodologies. https://lnkd.in/eNrwMTV9

FDA issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments,” which establishes a public docket that seeks comments to determine whether biosimilar product development would be best served by focusing on product class-specific guidance documents that address common development issues that apply to a broad class of products, or by developing product-specific guidance documents: https://lnkd.in/grC5S8gp Submit any comments regarding this notice to the public docket (Docket No. FDA-2024-N-3228) until October 24, 2024. Visit the Federal Register notice for additional information on how to comment.

Today, FDA issued the final guidance, "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products": https://lnkd.in/geANjjW7 The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements.