http://www.fda.gov/ en http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. Fri, 30 Jun 2023 17:08:12 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/whats-new-related-drugs http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions Information on patents and suitability petitions that impact the availability of generic drugs. Fri, 30 Jun 2023 17:06:09 EDT FDA http://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN, CV or NAA, distributed between September 2018 to September 2021, to the consumer level due to the presence of benzene in some samples of the products Fri, 30 Jun 2023 14:54:07 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-specific-lotriminr-and-tinactinr-spray-products-due-presence-benzene http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the prod Fri, 30 Jun 2023 14:44:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due http://www.fda.gov/news-events/press-announcements/fda-roundup-june-30-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 30 Jun 2023 14:29:50 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-june-30-2023 http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring FDA/CDER employment opportunities utilizing the FDA 21st Century Cures Act Hiring Authority Fri, 30 Jun 2023 14:20:42 EDT FDA http://www.fda.gov/about-fda/jobs-center-drug-evaluation-and-research-cder/we-are-hiring http://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/supporting-clinical-practice-guidelines-drugs-abuse-potential Information regarding the FDA's efforts to support the development of clinical practice guidelines for drugs with abuse potential. Fri, 30 Jun 2023 14:20:09 EDT FDA http://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/supporting-clinical-practice-guidelines-drugs-abuse-potential http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups. Fri, 30 Jun 2023 13:51:03 EDT FDA http://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots http://www.fda.gov/drugs/news-events-human-drugs/fda-cder-and-cber-duke-margolis-center-health-policy-rare-disease-endpoint-advancement-pilot-program The purpose of this public workshop is to discuss topics relevant to the development of endpoints for rare diseases. Fri, 30 Jun 2023 13:44:12 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/fda-cder-and-cber-duke-margolis-center-health-policy-rare-disease-endpoint-advancement-pilot-program http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-engagement-collaborative The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP). Fri, 30 Jun 2023 12:43:53 EDT FDA http://www.fda.gov/patients/learn-about-fda-patient-engagement/patient-engagement-collaborative http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 Innovative drugs often mean new treatment options for patients and advances in health care for the American public. Fri, 30 Jun 2023 11:16:52 EDT FDA http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022 http://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-roster This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee. Fri, 30 Jun 2023 07:07:41 EDT FDA http://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-roster http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster This page contains the Pulmonary-Allergy Drugs Advisory Committee roster, which lists the current members and the current number of vacancies for the committee. Fri, 30 Jun 2023 06:11:15 EDT FDA http://www.fda.gov/advisory-committees/pulmonary-allergy-drugs-advisory-committee/pulmonary-allergy-drugs-advisory-committee-roster http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents This page lists Recently Issued CBER and Cross-Center Guidance Documents. Thu, 29 Jun 2023 15:30:44 EDT FDA http://www.fda.gov/vaccines-blood-biologics/biologics-guidances/recently-issued-guidance-documents http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sleep-disorder-sedative-hypnotic-drug-information Sleep Disorder (Sedative-Hypnotic) Drug Information Thu, 29 Jun 2023 12:51:49 EDT FDA http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sleep-disorder-sedative-hypnotic-drug-information http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. Thu, 29 Jun 2023 11:26:35 EDT FDA http://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals http://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-drug-user-fee-program-omufa-understanding-fy-2023-user-fees-and-registration-05162023 Webinar provides an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describes the key elements of the program as it relates to OMUFA user fees. Thu, 29 Jun 2023 11:03:08 EDT FDA http://www.fda.gov/drugs/news-events-human-drugs/otc-monograph-drug-user-fee-program-omufa-understanding-fy-2023-user-fees-and-registration-05162023 http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. Thu, 29 Jun 2023 09:29:10 EDT FDA http://www.fda.gov/drugs/guidances-drugs/newly-added-guidance-documents http://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-rhinosinusitis-nasal-polyps-developing-drugs-treatment Clinical / Medical Thu, 29 Jun 2023 09:22:03 EDT FDA http://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-rhinosinusitis-nasal-polyps-developing-drugs-treatment http://www.fda.gov/consumers/consumer-updates Science-based health and safety information you can trust. Thu, 29 Jun 2023 08:59:09 EDT FDA http://www.fda.gov/consumers/consumer-updates