Search Results for FDAAA

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FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies By Michael Mezher - Published 22 September 2017

A paper appearing in the New England Journal of Medicine on Thursday argues that the US Food and Drug Administration (FDA) is not doing enough to ensure drugmakers complete postmarketing studies required by the agency at the time their drugs are approved.

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

Tags: Postmarketing Requirements, Postmarketing study, FDAAA

HHS Inspector General to Look Into Six FDA Programs in FY2016 By Zachary Brennan - Published 03 November 2015

Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: FDAAA, medical device tracking, supply chain, Medicare, Medicaid, OIG

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers By Alexander Gaffney, RAC, Michael Mezher, Zachary Brennan - Published 02 October 2017

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Priority Review Voucher, PRV, Neglected Tropical Disease, Neglected Tropical Disease Priority Review Voucher, Rare Pediatric Disease Voucher, Rare Pediatric Disease, FDASIA, FDAAA, Voucher, FDA Voucher, Guidance, AbbVie, United Therapeutics, Praluent

US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola By Alexander Gaffney, RAC - Published 12 November 2014

Legislators in the US Senate have unveiled a new piece of legislation meant to incentivize companies to go after the Ebola virus by making critical and long-sought changes to a US Food and Drug Administration (FDA) regulatory program.

Categories: News, US, FDA, Drugs

Tags: Ebola, Priority Review Voucher System, FDAAA, Priority Review, Legislation, Congress, Senate, HELP Committee, Tropical Disease Priority Review Voucher

To Meet Ebola Threat, Father of FDA's Priority Review Voucher System Calls for Reforms By Alexander Gaffney, RAC - Published 13 October 2014

One of the fathers of a little-known and lesser-used regulatory pathway meant to incentivize the approval of new drugs for so-called "neglected tropical diseases" says Congress needs to include Ebola on the short list of diseases eligible for incentives.

Categories: News, US, CDER, Drugs, Orphan products, Submission and registration

Tags: Priority Review, Voucher, Tropical Disease Priority Review Voucher, FDAAA, Tropical Disease, Ebola

DTC Broadcast Advertisements: The Evolution of Major Statements By Donato M. Forlenza, PharmD, MBA, and Nada A. Glavan, MPH - Published 25 September 2014

Direct-to-consumer (“DTC”) advertising has a long, robust regulatory history, mostly rooted in debates over the pros and cons of promoting a prescription drug directly to consumers. This article focuses on how the pharmaceutical industry communicates risk information in what can arguably be considered the most prominent and industry-preferred medium for healthcare advertising to consumers—broadcast advertising.

Categories: Features, US, Compliance, Drugs, Postmarket surveillance

Tags: direct-to-consumer advertising, history, FDAAA, enforcement actions

FDA Looks to Close Loophole That Could Delay Approval of Biosimilars By Alexander Gaffney, RAC - Published 10 March 2014

Categories: US, FDA

Tags: 351(k), 505(q), FDASIA, Citizen Petition, Latest News, FDAAA, biosimilar, FD&C Act

MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says By Alexander Gaffney, RF News Editor - Published 08 March 2013

Categories: FDA, CDRH

Tags: User Fees, Report, MDUFA, Latest News, FDAAA

FDA Slashes Fees for Priority Review Voucher By Alexander Gaffney - Published 12 September 2012

Categories: FDA

Tags: Tropical Disease, Voucher, Priority Review, Latest News, FDAAA

Post-FDAAA, Regulators Move to Adapt to Changing Risk Models By Alexander Gaffney - Published 01 June 2012

Categories: FDA, CDER

Tags: OSE, Dal Pan, AERS, Surveillance, Adverse Events, Postmarketing, Latest News, pharmaceutical, FDAAA, drug, REMS

Report: REMS Preventing Companies From Making Generic Medicines By Alexander Gaffney - Published 23 May 2012

Categories: FDA, FTC

Tags: Risk Management Plan, Competition, Generic, Latest News, pharmaceutical, FDAAA, safety, drug, REMS, risk

Considering Risk Evaluation and Mitigation Strategies (REMS) By Zachary Brousseau - Published 17 May 2012

Categories: Under RAPS, FDA

Tags: RiskMAP, Risk Evaluation and Mitigation Strategies, MedGuide, FDAAA, REMS

ClinicalTrials.gov: Requirements and Implementation Strategies By Elaine Wong, MS, and Rebecca Williams, PharmD, MPH - Published 08 May 2012

The Food and Drug Administration Amendments Act of 2007 (FDAAA) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov.  This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research findings. This article discusses key considerations, helpful hints and some lessons learned to help meet the requirements of FDAAA as well as the trial registration policy of the International Committee of Medical Journal Editors (ICMJE).

Categories: Features

Tags: Registering Clinical Trials, ClinicalTrials.gov, database, FDAAA, studies, clinical trials

IOM Issues Report on Studying Safety of Approved Drugs By Alexander Gaffney - Published 01 May 2012

Categories: FDA

Tags: Consensus Report, BRAMP, Postmarketing, IOM, Report, Latest News, FDAAA, Scientific, clinical trial, study, safety, ethical, REMS

Regulatory Environment Changes Affect REMS By Elaine Taylor and Kiley DePolo - Published 24 April 2012

One US Food and Drug Administration (FDA) requirement that has undergone an important change is the requirement for inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS). A recent guidance (November 2011) reduced the need for a REMS when a medication guide is the only REMS element.

Categories: Features

Tags: Medication Guide, Risk Evaluation and Mitigation Strategies, MedGuide, FDAAA, REMS, risk, regulatory

FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start By Alexander Gaffney - Published 04 April 2012

Categories: FDA

Tags: Grant, Funding, Reagan-Udall Foundation, Udall, Reagan, Postmarketing, Monitoring, Latest News, FDAAA, foundation, safety

New FDA Draft Guidance on DTC Television Advertisements By Alexander Gaffney - Published 12 March 2012

Categories: FDA

Tags: Ad, Dissemination, Television, DTC, Latest News, FDAAA, advertising, review

FDA Releases New Safety Communication Strategy By Alexander Gaffney - Published 08 March 2012

Categories: FDA, CBER, CDER

Tags: Public, Communication, Latest News, FDAAA, safety, information

FDA Releases Report on Postmarketing Study Requirements By Alexander Gaffney - Published 06 March 2012

Categories: FDA

Tags: PMC, Postmarketing, Pediatric, Latest News, FDAAA, PMR, requirements, Biologics

Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB By Alexander Gaffney - Published 07 February 2012

Categories: FDA

Tags: ID, Identification, UID, OMB, Latest News, FDAAA, regulation, medical device

FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA By Alexander Gaffney - Published 13 January 2012

Categories: FDA

Tags: Establishment, Listing, Waiver, Latest News, FDAAA, registration