FDA Drug Information

FDA releases final guidance on developing drugs for early Lyme disease.  Guidance focuses on localized & disseminated disease; covers trial design, safety & efficacy; & aims to support drug development. Learn more: fda.gov/regulatory-inf… #LymeDisease #FDAGuidance

FDA releases white paper on Selective Safety Data Collection. SSDC is the planned reduction in certain data collection for drugs with well-characterized safety profiles. White paper discusses trials that have used SSDC in oncology & cardiometabolic spaces. fda.gov/media/187763/d…

FDA approves first interchangeable rapid-acting insulin medication. Kirsty (insulin aspart-xjhz) is an interchangeable biosimilar to Novolog (insulin aspart). View the prescribing information: accessdata.fda.gov/scripts/cder/d…

Today, we announced the issuance of seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH). fda.gov/news-events/pr… While 7-OH is naturally present in kratom in trace amounts, the Agency is particularly concerned about…

FDA invites you to attend a public workshop on the development of interchangeable biosimilar products. Register here for virtual or in-person participation: fda.gov/industry/fda-p…

FDA invites you to attend the interim public meeting for the BsUFA III Regulatory Science Pilot Program. Register here: fda.gov/news-events/fd…

The CDER Center for Clinical Trial Innovation (C3TI) demonstration project on Bayesian methods is expanding its scope to include pre-specified primary analysis and trial monitoring, in addition to its previous focus on supplementary analysis. Learn more: fda.gov/about-fda/cder…

FDA grants accelerated approval to a treatment for non-small cell lung cancer. fda.gov/drugs/resource…

FDA grants accelerated approval to a treatment for relapsed or refractory multiple myeloma. fda.gov/drugs/resource…

CDER released its 9th annual 2024 Drug Trials Snapshots report, which summarizes the demographic representation in the clinical trials that supported the 50 novel drugs approvals in 2024. 31,000 patients participated in these clinical trials. Learn more: fda.gov/drugs/drug-app…

FDA grants accelerated approval to a treatment for EGFR-mutated non-small cell lung cancer. fda.gov/drugs/resource…

FDA approves a treatment for relapsed or refractory follicular lymphoma. fda.gov/drugs/resource…

FDA is still accepting applications until June 30, 2025, for the Rare Disease Endpoint Advancement (RDEA) Pilot Program which supports novel efficacy endpoint development for drugs that treat rare diseases. Learn more & submit your application today ➡️ fda.gov/drugs/developm…

FDA announces the availability of the 2024 Office of Clinical Pharmacology Annual Report: fda.gov/media/187053/d…

#FDA approves a treatment for adults with resectable locally advanced head and neck squamous cell cancer whose tumors express PD-L1. fda.gov/drugs/resource…

FDA approves a treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. fda.gov/drugs/resource…

FDA approves a treatment for ROS1-positive non-small cell lung cancer. fda.gov/drugs/resource…

FDA proposes requirements for minor dosage form changes for certain OTC monograph drugs from tablets/capsules to chewable tablets, orally disintegrating tablets, or films. Draft guidance also released. Public comments open. dps.fda.gov/omuf #FDA #OTCDrugs