CDER is committed to accelerating the development of treatments for patients with rare diseases. Last year, CDER launched the Accelerating Rare disease Cures (ARC) Program. In its first year, the ARC Program has focused on strengthening partnerships with external stakeholders.

Thank you to the OGD staff for all your continued efforts to advance science and research and maintain a thriving generic drug review process. This report and the Voices article highlight OGD’s significant progress and their diligent work in 2022: fda.gov/news-events/fd…

One of FDA’s top priorities is ensuring the safety, quality, and effectiveness of the drug products available to the American public. All FDA-regulated drug products imported into the U.S. must comply with the same standards as domestic products: fda.gov/drugs/news-eve…

FDA just published a guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices (DCTs). #clinicaltrials #DCT #decentralizedtrials fda.gov/regulatory-inf…

We're taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics & devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. fda.gov/news-events/pr…

The FDA has long considered the benefits of decentralized clinical trials. Advancements in digital health technologies & the #COVID19 pandemic—when in-person visits were limited or unavailable for many trial participants—have accelerated the broader adoption of these activities.

FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing fda.gov/news-events/fd… #ArtificialIntelligence #drugdevelopment #clinicaltrials #FDA

This new FDA Voices piece discusses two papers on artificial intelligence (AI) and machine learning (ML) in drug development and manufacturing: fda.gov/news-events/fd…

FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech healthcaredive.com/news/fda-regul… via Healthcare Dive

Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States.

The approval of the second nonprescription naloxone product is an important step in increasing availability and access to this life-saving medication to treat opioid overdoses and in providing additional nonprescription options to be sold directly to consumers.

At #RAForum, an expert panel led by William Brangham is chatting now about how #AI is being used in drug discovery & development. Speakers: -Tala, PhD, MPH, CDER U.S. FDA -Jakub Kostal, PhD GW University -David Reese, MD, Amgen 🧪🔬🧬

I'm beyond thrilled with the beautiful cover the art team at W. W. Norton & Company created for my book! Swimming Pretty is forthcoming in June 2024 but already available for preorder! amazon.com/Swimming-Prett… #synchro #artisticswimming #swimming #swimmingpretty

Join #CDERSBIA on Dec 6-7 for the FDA Clinical Investigator Training Course (CITC) 2023 to learn about regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Register & lean more ➡️ fda.gov/drugs/news-eve…

Don't miss the FDA Office of Women’s Health & FDA Drug Information Office of Medical Policy’s (OMP) free public webinar Bringing Clinical Research to Patients Nov. 8 from 12 - 1 p.m. ET. Register now to learn more and to join the conversation. Click here ➡️: ow.ly/5psh50Q43MV

Thank you for joining us for our webinar: Bringing Clinical Research to Patients. We'll be posting a recording of this webinar soon #ICYMI or want to see a replay. You can watch it here: ow.ly/af3M50Q5BqK #ClinicalTrials #WomensHealth

Here’s the thing, you can be Against Hamas Against killing of Palestinians Against killing of Israelis Against anti-Semitism Against Islamophobia Against hostage taking Against arbitrary detentions Against occupation Against displacement Against rockets &bombardment ALL at once

Swimming Pretty got a Kirkus star and I'm thrilled! Thank you for the lovely writeup, Kirkus Reviews ! kirkusreviews.com/book-reviews/v…

Please join Commissioner Dr. Robert M. Califf to kick off tomorrow’s REdI Conference 2024 and stay as I join FDA Medical Devices Director Dr. Jeff Shuren & FDA Biologics Director Dr. Peter Marks for the plenary to discuss innovation in medical product development: fda.gov/REdI2024

What a wonderful surprise to see Swimming Pretty as a staff pick on NPR's Books We Love list for 2024! 😍 I'm not only honored but also having fun discovering a bunch more books to add to my reading que! 📚 apps.npr.org/best-books/#ye…