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Public Hearing: Future Format of the National Drug Code
… /drugs/news-events-human-drugs/public-hearing-future-format-national-drug-code … 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 Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools
… The Food and Drug Administration (FDA) will hold a public hearing to provide an opportunity for broad public … media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, … in any other pertinent information participants in the hearing would like to share. FDA has obtained significant …
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 …
UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - 10/17/2022
… y-committee-calendar/updated-information-october-17-19-2022-hearing-announcement-involving-obstetrics-reproductive-and … … slides were updated to reflect what was shown during the hearing. UPDATED INFORMATION (as of October 19, 2022): The … ANDA holders, wishing to make a formal presentation at the hearing must register at the following link by 5:00 p.m. EDT …
UPDATED PUBLIC PARTICIPATION INFORMATION: October 17 -19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee - 10/17/2022
… updated-public-participation-information-october-17-19-2022-hearing-announcement-involving … UPDATED INFORMATION (as of … 2 p.m. to 4 p.m. Eastern Time on the first day of the hearing and from 8 a.m. to 10 a.m. on the second day. Persons interested in participating in the hearing by making an oral presentation during the 4 hours …
Public Hearing on Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007
… … Public Hearing on Use of Medication Guides to Distribute Drug Risk … for Drug Evaluation and Research (CDER) will hold a public hearing to obtain feedback on FDA’s Medication Guide program, … who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested …
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act
… also outlines the procedures for an administrative hearing (hearing) related to a final order. Finally, this guidance …
Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007
… a standard distribution system. The FDA was urged at the hearing to increase awareness of Medication Guides, make … for Drug Evaluation and Research … Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug … to Patients June 12-13, 2007 … Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug …
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing - 09/17/2019 - 09/17/2019
… Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019 entitled, “Standards for Future … for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the … B/C Silver Spring, MD 20993-0002 The entrance for public hearing participants (non-FDA employees or contractors) is …
UPDATED MEETING TIME AND OPEN PUBLIC HEARING TIME: March 30, 2022: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement - 03/30/2022
… ugs-advisory-committee/updated-meeting-time-and-open-public-hearing-time-march-30-2022-meeting-peripheral-and-central … … to 10:00 a.m. – 5:00 p.m. Additionally, the Open Public Hearing time has changed from 1:30 p.m. – 2:30 p.m. to 1:55 … reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the …
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 …
Public Meeting on Patient-Focused Drug Development for Systemic Sclerosis - 10/13/2020 - 10/13/2020
… Development for Systemic Sclerosis. FDA was interested in hearing patients’ perspectives on the impact of systemic … Development for Systemic Sclerosis. FDA is interested in hearing patients’ perspectives on the impact of systemic …
Tahsildar, Hassan - NOOH Letter 7/13/18
… MD (b)(6) PROPOSAL TO DEBAR NOTICE OF OPPORTUNITY FOR HEARING DOCKET No. FDA-2018-N-1996 Dear Dr. Tahsildar: This … This letter also offers you an opportunity to request a hearing on this proposal, and provides you with the relevant … factor. Proposed Action and Notice of Opportunity for Hearing Based on the findings discussed above, FDA has …
Kuo, Su-Chiao, M.D. - NOOH Letter 7/13/18
https://www.fda.gov/regulatory-information/electronic-reading-room/kuo-su-chiao-md-nooh-letter-71318
… Kuo, MD (b)(6) PROPOSAL TO DEBAR NOTICE OF OPPORTUNITY FOR HEARING DOCKET No. FDA-2018-N-1990 Dear Dr. Kuo: This letter … This letter also offers you an opportunity to request a hearing on this proposal, and provides you with the relevant … factor. Proposed Action and Notice of Opportunity for Hearing Based on the findings discussed above, FDA has …
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 …
For Industry: Using Social Media
… providers. In November 2009, FDA held a Part 15 public hearing to gather comments and questions from our … using the Internet and social media tools. The public hearing was instrumental in providing an opportunity for our … that address various topics related to the public hearing. We look to continue our work in this ever-evolving …
FDA D.I.S.C.O. Burst Edition: FDA approval of Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors
… of patients with Brock Grade greater than or equal to 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 …
Avastin (bevacizumab) Information
… please see the FDA Archive Update, 6/29/2011 The public hearing on the Center for Drug Evaluation and Research’s … families, and other stakeholders who participated in the hearing and have shared their perspectives with us over the … supporting its request for a Notice of Opportunity for a Hearing. The information has been submitted to the docket …
Small Business Assistance: Frequently Asked Questions on the Patent Term Restoration Program
… for revision, due diligence petition, or request for a hearing. 11. How is the length of the patent extension … has been submitted to FDA . 15. What is a Due Diligence Hearing? Any person may request not later than 60 days after … due diligence determination that FDA conduct an informal hearing on the due diligence determination. Information …
Questions and Answers about Avastin
… must provide the company with the chance to request a hearing by issuing a Notice of Opportunity for a Hearing (NOOH). The agency issued the NOOH today. Genentech will have 15 days to request a hearing in writing. If Genentech does not request a hearing, …
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 …
Methylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and Kudco
… is announcing an opportunity for the firms to request a hearing on the proposal. As part of this process, the FDA is publishing Notices of Opportunity for Hearing (NOOHs) on its Proposals to Withdraw Marketing … in the U.S. Each NOOH explains that the firm may request a hearing to show why approval of their ANDA should not be …
2022 Meeting Materials, Obstetrics, Reproductive and Urologic Drugs Advisory Committee (formerly Bone, Reproductive and Urologic Drugs Advisory Committee)
… Committee Meeting Announcement October 17–19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, … Urologic Drugs Advisory Committee October 17 -19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, … and Urologic Drugs Advisory Committee October 17–19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, …
Rulemaking History for OTC Antitussive Drug Products
… Products: Benylin Proposed Rule Date FR Citation Notice: Hearing on unapproved NDA [PDF] 11/30/1976 41FR52537 Final … Meeting [PDF] 10/1/2007 72FR55784 Notice of Public Hearing: Request for comments [PDF] 8/25/2008 73FR50033 Notice of Public Hearing: Correction [PDF] 9/2/2008 73FR51309 Antitussive Drug …