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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

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,

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

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Tags: Guidance, Draft Guidance, MDAC, Medical Device Advisory Committee, AdComm, Advisory Committee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

Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds By Alexander Gaffney, RAC - Published 09 January 2015

Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues.

Categories: News, US, FDA, Ethics

Tags: FDA Advisory Committee, AdComm, Advisory Committee, Conflict of Interest, COI, Conflict-of-Interest, Study

FDA Appoints Members to New, Influential Advisory Committee By Alexander Gaffney, RAC - Published 16 December 2014

Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.

Categories: News, US, CDER, Drugs

Tags: PCAC, Pharmacy Compounding Advisory Committee, Difficult-to-Compound List, AdComm, Advisory Committee

FDA Announces a Secretive Meeting to Discuss an Unknown Drug for Unknown Reasons By Alexander Gaffney, RAC - Published 10 November 2014

The US Food and Drug Administration (FDA) regularly convenes panels of its various Advisory Committees to offer the agency advice on a wide range of regulatory topics—everything from general policy recommendations to specific advice on a particular drug or drug class. Not all of its meetings are public, however.

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

Tags: Advisory Committee Meeting, AdComm, FDA Advisory Committee Meeting, Secret, RUDAC, DSRMAC

After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics By Alexander Gaffney, RAC - Published 28 July 2014

The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers.

Categories: News, US, CDER, Over the counter drugs, Postmarket surveillance

Tags: NDAC, Antiseptic, OTC, AdComm, Nonprescription Drug Advisory Committee

Meet BRUDAC, FDA's Old Committee With a New Name and Charge By Alexander Gaffney, RAC - Published 10 April 2014

Categories: US, FDA

Tags: ACRHD, BRUDAC, AdComm, Latest News, advisory committee

After Controversy, FDA Finalizes New Policy on Advisory Committee Transparency By Alexander Gaffney, RAC - Published 01 April 2014

Categories: US, FDA

Tags: SGE, Waiver, AdComm, Latest News, advisory committee, guidance

Project Teams for Regulatory Advisory Committees By David S. Mantus, PhD - Published 11 March 2014

Categories: Features, FDA

Tags: Successful Advisory Committee, FDA Advisory Committee, Regulatory Project Teams, AdComm, advisory committee

Group Claims FDA Being Overly Secretive with Advisory Committee Member Information By Alexander Gaffney, RAC - Published 05 February 2014

Categories: US, FDA

Tags: AdComm, advisory committee

Process of Joining FDA's Advisory Committees Becomes (A Little Bit) Easier By Alexander Gaffney, RAC - Published 22 January 2014

Categories: Meetings, US, FDA

Tags: AdComm, Latest News, advisory committee

February to see Flurry of FDA Advisory Committee Meetings By Alexander Gaffney, RAC - Published 08 January 2014

Categories: Meetings, US, FDA

Tags: AdComm, Latest News, advisory committee

FDA Extends Comment Period on Cell and Gene Therapy Guidance by Six Months By Alexander Gaffney, RF News Editor - Published 19 November 2013

Categories: US, FDA

Tags: Cell Therapy, Gene Therapy, AdComm, draft guidance

Improving Public Participation and Transparency at FDA with Earlier Availability of Advisory Committee Materials By Mitchell Berger, MPH, RAC - Published 15 July 2013

This article provides an overview of statutory and regulatory provisions, policies and FDA guidance documents governing the timing of release of materials for Advisory Committee meetings. This review suggests that Advisory Committee materials subject to public disclosure should be publicly released further in advance of the Advisory Committee meeting.

Categories: US, FDA

Tags: Transparency, AdComm, Perspective, advisory committee, guidance

FDA Calls on Public to Fill Dozens of Open Device-Related Advisory Committee Seats By Alexander Gaffney, RF News Editor - Published 06 February 2013

Categories: FDA, CDRH

Tags: AdComm, Latest News, advisory committee, medical device

Does Advisory Committee Transparency Lead to Better Regulatory Decision Making? By Alexander Gaffney, RF News Editor - Published 29 January 2013

Categories: FDA

Tags: COI, Vioxx, Conflict of Interest, Transparency, AdComm, Latest News, advisory committee, regulatory

Consumer Advocacy Group Fires Back at FDA Over Transparency of Advisory Committees By Alexander Gaffney, RF News Editor - Published 12 November 2012

Categories: FDA

Tags: Drospirenone, POGO, Yasmin, Yaz, Bayer, AdComm, Latest News, advisory committee

FDA Advisory Committee to Assess 'Warning Fatigue' By Alexander Gaffney - Published 11 October 2012

Categories: FDA

Tags: Message Fatigue, Warning Fatigue, RCAC, AdComm, Latest News, advisory committee, risk

FDA Seeks Industry Nominees for Pediatric Advisory Committee By Alexander Gaffney - Published 09 August 2012

Categories: FDA

Tags: Pediatric Advisory Committee, AdComm, Latest News, advisory committee

FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve By Alexander Gaffney - Published 12 June 2012

Categories: FDA

Tags: THV, Sapien, Circulatory Systems Advisory Committee, Edwards, AdComm, Meeting, Latest News

Advisory Committee Lends Limited Support to Pfizer's Tafamadis By Alexander Gaffney - Published 25 May 2012

Categories: FDA

Tags: CNSDAC, Vyndaqel, Tafamadis, FAP, Pfizer, CNS, AdComm, Latest News, advisory committee

FDA Panel Recommends Restarting Testing of Controversial Pain Drugs By Alexander Gaffney - Published 13 March 2012

Categories: FDA, CDER, Drugs

Tags: Nerve, Arthritis, AAC, Pain, Anti-NGF, Pharmaceuticals, AdComm, Latest News, advisory committee, clinical trials