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Drug Approvals and Databases FDA

(9 days ago) WebDrug and Biologic Approval and IND Activity Reports. Drug Trials Snapshots. Oncology (Cancer) / Hematologic Malignancies Approval Notifications. FDALabel. FDA Online …

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Find Information about a Drug FDA

(4 days ago) WebOffice of Communications. 10001 New Hampshire Ave. Hillandale Building, 4th Fl. Silver Spring, MD 20993. [email protected--> Toll Free. (855) 543-3784. (301) 796-3400. …

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New Drug Therapy Approvals 2022 FDA

(Just Now) WebOpzelura (ruxolitinib) cream was first approved in 2021 for atopic dermatitis. In 2022, CDER approved the drug to treat nonsegmental vitiligo, a condition that involves loss of skin …

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Resources for You Drugs FDA

(5 days ago) WebFor Consumers, Health Professionals, and Industry. Find resources to answer regulatory and drug-related questions. Not intended to be an all-inclusive source, but instead …

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FDA approves updated drug labeling including new indications

(6 days ago) WebProject Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies, and substantial post-marketing experience. For …

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FDA announces Evusheld is not currently authorized for …

(9 days ago) WebUpdate [1/26/2023] The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit …

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Information by Drug Class FDA

(7 days ago) WebFDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, …

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2023 Meeting Materials, Peripheral and Central Nervous System …

(8 days ago) WebMarch 22, 2023: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. March 22, 2023: Meeting of the Peripheral and Central Nervous System …

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FDA D.I.S.C.O. Burst: Tecentriq and Krazati

(9 days ago) WebListen to a soundcast of the December 9 and 12, 2022, FDA approvals of Tecentriq (atezolizumab) for unresectable or metastatic alveolar soft part sarcoma, and Krazati …

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FDA Concludes that Existing Regulatory Frameworks for Foods and

(Just Now) WebThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and …

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Drug Safety and Availability FDA

(4 days ago) WebDrug Safety and Availability. Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of …

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FDA Approved Many New Drugs in 2022 That Will Improve the …

(7 days ago) WebWe also approved drugs in new settings, such as for new uses and patient populations. Patrizia Cavazzoni, M.D. The 2022 approvals target many different disease areas. For …

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February 9, 2023: Oncologic Drugs Advisory Committee Meeting

(7 days ago) WebUPDATED INFORMATION (as of January 23, 2023): The meeting time, agenda, public participation information, and contact information have been updated for the February 9, …

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Meeting of the Peripheral and Central Nervous System Drugs

(Just Now) WebAgenda. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application …

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FDA’s Labeling Resources for Human Prescription Drugs

(7 days ago) WebThe Generic Drugs – Specific Labeling Resources webpage includes information about requirements for generic drug labeling, recommendations on updating generic drug …

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Guidances Drugs FDA

(4 days ago) WebNewly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and …

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General Drug Categories FDA

(Just Now) WebAntiemetics: Drugs used to treat nausea and vomiting. Antifungals: Drugs used to treat fungal infections, the most common of which affect the hair, skin, nails, or mucous …

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Optimizing the Dosage of Human Prescription Drugs and …

(8 days ago) WebThis guidance is intended to assist sponsors in identifying the optimal dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during …

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January 24, 2023: Antimicrobial Drugs Advisory Committee Meeting

(3 days ago) WebJanuary 24, 2023 Meeting of the Antimicrobial Drugs Advisory Committee- FDA Briefing Document- Errata pdf (66.38 KB) January 24, 2023 Meeting of the Antimicrobial Drugs …

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(5 days ago) Webwww.accessdata.fda.gov

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Drug Shortages FDA

(2 days ago) WebCoronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and …

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PDUFA and BsUFA Quarterly Hiring Updates FDA

(7 days ago) WebAs part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III), the Food and Drug Administration (FDA) committed …

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Now Available Without a Prescription FDA

(1 days ago) WebThe drugs must still be effective for the short-term symptoms for which they're intended. The issue of whether a condition can be self-diagnosed was a central one for the …

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