FDA’s Post

FDA has released an immediately-in-effect guidance titled "Temporary Policies for Compounding Certain Parenteral Drug Products": https://lnkd.in/gdhzHhwf Please see the Information on Compounding section for more information: https://lnkd.in/gsicYEtg FDA has added three new parenteral drug products to the Drug Shortages Database. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.

💡 Treating MS patients? This course for neurologists, NPs, PAs, and more will help you identify biosimilar treatment options, reduce patient reluctance, and improve care. Enroll: https://bit.ly/4gs11wn

Recording now available of the September 25, 2024, public meeting: Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food. Submit electronic comments to the docket FDA-2024-N-3609 on or before December 6, 2024. https://lnkd.in/dKsjpH5E

We thank all the supply chain professionals for their contributions to patient care and for the many ways they support patients, health care organizations, and communities by ensuring access to #MedicalDevices. As we wrap up National Health Care Supply Chain Week, we remind you that our Office of Supply Chain Resilience (OSCR) protects public health by identifying #SupplyChain risks and providing actionable information on those risks to health care delivery organizations, patients, health care workers, medical device manufacturers, medical device distributors, and government partners. Learn more: https://bit.ly/3BlaWnh #SCWeek

It’s #TalkAboutPrescriptions Month!    Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, patients, and their caregivers. Check out these FAQs for healthcare providers to learn more: https://lnkd.in/gBKfWdHP 

We issued the final guidance, Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway. Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria identified in the guidance to support substantial equivalence. Find out more: https://lnkd.in/eddSPjbK

The U.S. Food and Drug Administration is accepting drug companies’ proposals to participate in the fiscal year 2025 site visitation program: https://lnkd.in/ghFPE2uC In this program, FDA staff observe operations of commercial manufacturing, pilot plants, and testing operations to gain a better understanding of the pharmaceutical industry and its operations, as well as the challenges impacting a drug’s developmental program and commercial life cycle. FDA encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to participate. The agency will select facilities based on priorities for FDA staff training, a facility’s current compliance status with FDA, and other considerations. This program does not supplement or replace a regulatory inspection. Starting October 1, companies interested in offering a site visit or learning more about this program should submit a proposal to [email protected].

Here’s a quick update on the at-home testing options available for respiratory viruses.

Recent grads, come work for us! We've just posted a new opportunity to join our Office of External Affairs as a Program Support Specialist! Check out this listing for more on the position and eligibility.

October 10 is #OmbudsDay and our Ombudsman Program, led by Abiy Desta and Ken Skodacek, ✅ hear concerns from device manufacturers, consumers, and CDRH staff; ✅provide potential options for consideration; and ✅support the resolution of both external and internal conflicts. This year, we asked our Ombudsmen a few questions to get a better understanding of how they support the public and our Center.