Search Results for Advisory Committee

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FDA Holds First Patient Engagement Advisory Committee Meeting By Michael Mezher - Published 12 October 2017

The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices.

Categories: News, US, FDA, Clinical, Medical Devices

Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information

Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device advisory committee meetings

Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments By Zachary Brennan - Published 05 July 2017

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive sizable sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Ethics, Regulatory intelligence, Regulatory strategy

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

FDA to Hold One Advisory Committee for Each Initial Biosimilar By Zachary Brennan - Published 13 September 2016

The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each first new biosimilar for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar advisory committee, critical quality attributes

FDA Panel Unanimously Backs Amgen’s Humira Biosimilar By Zachary Brennan - Published 12 July 2016

The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab).

Categories: News, US, FDA, Biologics and biotechnology

Tags: AAC, advisory committee vote, Humira

FDA Issues New Guidance on Conflict of Interest for Advisory Committee Members By Michael Mezher - Published 28 June 2016

The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices

Tags: Conflict of Interest, Advisory Committee

FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest By Zachary Brennan - Published 09 May 2016

The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest.

Categories: News, US, CDRH, Clinical, Crisis management, Medical Devices, Regulatory intelligence

Tags: medical device panel, St. Jude Medical, Amplatzer, PFO Occluder, FDA advisory committee, conflict of interest

Public Citizen Sues FDA Over Redacted Advisory Committee Info By Michael Mezher - Published 28 April 2016

The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members.

Categories: News, US, FDA, Government affairs

Tags: Public Citizen, Advisory Committee Members, Freedom of Information,

Academic DMD Experts Criticize ‘Errors’ in FDA Ad Com Briefing Documents By Zachary Brennan - Published 21 March 2016

More than 35 medical professors and experts have criticized the US Food and Drug Administration’s (FDA) review of a Duchenne Muscular Dystrophy (DMD) drug, citing errors in the agency’s advisory committee meeting briefing documents.

Categories: US, CDER, Clinical, Crisis management, Drugs

Tags: DMD, Sarepta, eteplirsen, advisory committee briefing documents

FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs By Michael Mezher - Published 16 March 2016

The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells.

Categories: News, CBER, Biologics and biotechnology, Clinical, Manufacturing, Research and development

Tags: CAR T-cells, chimeric antigen receptors, CD19, Recombinant DNA Advisory Committee, Cancer, Oncology, Juno, Kite, Novartis, B-cell lymphoma, Investigational new drug application, IND

FDA Sees Spike in Gene and Cell Therapy Applications By Zachary Brennan - Published 16 February 2016

The US Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met Tuesday to discuss updates of research programs in the Office of Cellular, Tissue and Gene Therapy (CTGT), which is part of FDA’s Center for Biologics Evaluation and Research (CBER).

Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Research and development, Submission and registration

Tags: cell and gene therapies, Cellular, Tissue and Gene Therapies Advisory Committee, FDA advisory committee

FDA Advisory Committee Calendar By Tarius - Published 04 October 2017

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions By Christen M. Anderson, MD, PhD - Published 22 December 2015

The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities.

Categories: Features, US, FDA, Communication, Postmarket surveillance

Tags: Post-marketing Plans, Advisory Committee Meetings

Preparing for an FDA Advisory Committee Approval Meeting By Michael Vivion - Published 03 December 2015

This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Business and Leadership, Communication, Drugs, Government affairs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Advisory Committee Meetings, AdComm,

Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions By Zachary Brennan - Published 30 September 2015

The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Government affairs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: drug compounding, fungal meningitis, Pharmacy Compounding Advisory Committee, quinacrine hydrochloride

Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings? By Natalie Vargas, MPH, MBA - Published 30 September 2015

This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting.

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Submission and registration

Tags: Advisory Committee Meetings, Open Public Hearing,

FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee By Zachary Brennan - Published 18 September 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices.

Categories: News, US, CDRH

Tags: CDRH, patient engagement, advisory committee, PEAC, Robert Califf

FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen By Alexander Gaffney, RAC - Published 21 May 2015

The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen.

Categories: News, US, CDER, Drugs

Tags: PCAC, Pharmacy Compounding Advisory Committee, Pharmaceutical Compounding, Compounding

What Influences CDER Advisory Committee Members? By Lara Burgess, PhD, RAC, Virginia Cox, JD, Bert Regeer, MD - Published 15 May 2015

Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.

Categories: Features, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: CDER Advisory Committee, Advisory Committee, FDA Advisory Committee, CDER Advisory Panel, Influence

UPDATED: New to FDA's Advisory Committee Briefing Documents: Patient Testimony By Alexander Gaffney, RAC - Published 28 April 2015

Patients and their advocates appear to be getting more prominent attention from the US Food and Drug Administration (FDA) if a recent release of documents in advance of an upcoming advisory committee meeting is any indication.

Categories: News, US, FDA, Regulatory strategy

Tags: Patient Testimony, Advisory Committee

FDA Seeks Industry Representation on 17 of its Drug Advisory Committees Published 15 April 2015

The US Food and Drug Administration (FDA) is reaching out to the pharmaceutical and biopharmaceutical industries for input on which industry experts should serve on 18 of its influential advisory committees.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Advisory Committee, AdComm, Industry Representative

FDA Gives New Name, Authority to One of its Advisory Committees By Alexander Gaffney, RAC - Published 03 April 2015

The US Food and Drug Administration (FDA) has formally announced it will rename its Anti-Infective Drugs Advisory Committee (AIDAC), just weeks after announcing the committee would now oversee all HIV and AIDS drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: Advisory Committee, Antimicrobial Drugs Advisory Committee, Antiviral Drugs Advisory Committee

What you Need to Know About Meeting With FDA's Medical Device Advisory Committee By Alexander Gaffney, RAC - Published 31 March 2015

For many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances at a timely approval.

Categories: News, US, CDRH, Medical Devices, Regulatory strategy

Tags: Guidance, Draft Guidance, MDAC, Medical Device Advisory Committee, AdComm, Advisory Committee

Updated: FDA Disbands Advisory Committee in Charge of Review of HIV, AIDS Drugs By Alexander Gaffney, RAC - Published 20 March 2015

The US Food and Drug Administration (FDA) has disbanded its Antiviral Drugs Advisory Committee, a committee charged with the review of products intended to treat HIV and AIDS, the agency announced this week.

Categories: News, US, FDA, Drugs

Tags: HIV, AIDS, Advisory Committee, AdComm, Antiviral Drugs Advisory Committee, Anti-viral Drugs Advisory Committee

After Weathering Scandals, UK Appoints New Medical Device Oversight Official By Michael Mezher - Published 18 February 2015

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has appointed a prominent academic figure, Dr. Peter Nightingale, to be the chair of its newly formed expert group on medical devices—a position intended to help UK regulators strengthen oversight of the UK's medical device sector.

Categories: News, Europe, MHRA, Government affairs, Medical Devices

Tags: DEAC, Devices Expert Advisory Committee, Committee on the Safety of Devices, CSD