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Public Hearing: Future Format of the National Drug Code - 11/05/2018 - 11/05/2018
… /drugs/news-events-human-drugs/public-hearing-future-format-national-drug-code-11052018-11052018 … The FDA held a public hearing on November 5, 2018, regarding the future format of … out of 5-digit labeler codes, FDA is holding this public hearing to receive input from stakeholders on how to maximize …
Public Meeting on Patient-Focused Drug Development for Vitiligo - 03/08/2021 - 03/08/2021
… Drug Development for Vitiligo. FDA was interested in hearing patients’ perspectives on the impact of vitiligo on … Drug Development for Vitiligo. FDA is interested in hearing patients’ perspectives on the impact of vitiligo on …
Makena (hydroxyprogesterone caproate injection) Information
… Approval of Makena CDER Statements 1/18/2023 – Public Hearing Held on October 17–19, 2022 On October 17–19, 2022, … of the Food and Drug Administration conducted a hearing under 21 CFR 314.530 on the Center for Drug … Pharma Group/Covis Pharma GmbH (Covis). As part of the hearing, the Obstetrics, Reproductive and Urologic Drugs …
FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors
… outcome was the percentage of patients with Brock Grade ≥1 hearing loss, assessed using pure tone audiometry after … at least 3.5 years, whichever was later. The incidence of hearing loss was lower in the sodium thiosulfate and … non-metastatic solid tumors. The primary outcome was hearing loss according to American Speech-Language-Hearing …
CDER proposes withdrawal of approval for Makena
… the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of Makena, AMAG … mandates their removal. If AMAG Pharmaceuticals requests a hearing, the FDA Commissioner will determine whether to hold a public hearing and, following such hearing, decide whether to …
CDER perspective on recently published results of EPPPIC meta-analysis
… PTB. Currently, AMAG Pharmaceuticals has requested a hearing regarding CDER’s proposal to withdraw Makena’s … Office will determine whether to hold a public hearing and, following such hearing, decide whether to withdraw approval of Makena and …
October – December 2013 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… tablets, and CDER issued notices of opportunity for hearing to withdraw approval of those products. Specifically, …
OTC Drug Review Process | OTC Drug Monographs
… are subject to dispute resolution, an administrative hearing, and judicial review. FDA-Initiated Order FDA issues … are subject to dispute resolution, an administrative hearing, and judicial review. Expedited Procedure for …
FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes
… such as seizures that will not stop, hallucinations (hearing or seeing things that are not real), shaking, … such as seizures that will not stop, hallucinations (hearing or seeing things that are not real), shaking, …
Drug Trial Snapshot: TEPEZZA
… Fatigue a 10 (12%) 6 (7%) Hyperglycemia b 8 (10%) 1 (1%) Hearing impairment c 8 (10) 0 Dysgeusia 7 (8%) 0 Headache 7 … asthenia b Hyperglycemia includes blood glucose increase c Hearing impairment (includes deafness, eustachian tube …
FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines
… treatments. Symptoms of schizophrenia include hearing voices, seeing things that are not there, and being … improve the symptoms of schizophrenia in patients, such as hearing voices, seeing things that are not there, and being …
FDA Expands CDER NextGen Portal
… related to a final administrative order, administrative hearing requests related to a final administrative order, and …
Phasing Out of the COVID MyStudies Application (App)
… The Agency provided the COVID MyStudies resource after hearing that investigators were having difficulties obtaining …
FDA approves first enzyme replacement therapy for rare alpha-mannosidosis
… often include mild to moderate intellectual disability, hearing loss, weakened immune system, distinctive facial …
Over-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
… related to a final administrative order, administrative hearing requests related to a final administrative order, and …
January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… need for regulatory action. Tepezza (teprotumumab-trbw) Hearing impairment FDA is evaluating the need for regulatory …
October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… (oral/intravenous) metronidazole-containing products Hearing impairment FDA is evaluating the need for regulatory …
FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
… or confusion feeling anxious hallucinations (seeing or hearing things that are not really there) irritability memory … or confusion feeling anxious hallucinations (seeing or hearing things that are not really there) irritability memory …
Rulemaking History for OTC Topical Antimicrobial Drug Products
… Miscellaneous products 12/31/2003 68FR75585 Notice: Public Hearing and Request for Comment 11/21/2012 77FR69863 Proposed …
FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)
… adverse events such as gastrointestinal symptoms, hearing loss, rash, electrolyte imbalance, and drug …
FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)
… help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being …
Patient Medication Information (PMI)
… Medication Information Sep. 27-28, 2010: FDA Part 15 Hearing, Developing and Distribution of Patient Medication …
Proposed Rule on Revising the National Drug Code Format
… and Animal Drugs and Listing . In 2018, FDA held a public hearing about several proposed formatting options FDA could …
FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects
… Feelings of mistrust towards others (paranoia) Seeing or hearing things that are not there (hallucinations) Depression …
Education Efforts to Help Increase Biosimilar Understanding and Acceptance
… videos also include closed captioning for individuals with hearing impairment and an auto-translate feature with more …