Search Results for Risk

Showing 1 – 25  of 74

FDA Weighs Limited Risk Info in DTC Ads By Michael Mezher - Published 21 August 2017

The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented.

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

Tags: Advertising, DTC, Risk, Major Statement

Organizational Culture and Memory in Managing Risk in the Medical Device Industry By Darin Oppenheimer, PhD, Suraj Ramachandran, MS, RAC - Published 15 August 2017

This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."

Categories: Features, US, FDA, Business Skills, Medical Devices

Tags: Risk Management, Organizational Culture

FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads By Michael Mezher - Published 07 August 2017

A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: Direct-to-Consumer, DTC, Drug Advertising, Risk, Fair Balance

FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies By Michael Mezher - Published 24 July 2017

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

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

Tags: Informed Consent, Minimal Risk, 21st Century Cures

FDA Hedges: A Proposal to Better Share R&D Risks By Zachary Brennan - Published 19 April 2017

The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval process.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics

Tags: R&D risk, pharmaceutical risks, FDA hedges

House Committee Probes Restricted Distribution Systems Delaying Generics By Michael Mezher - Published 24 March 2017

The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.

Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies

Ethics and Risk Management: Lessons from the VW Defeat Device By Meredith May, MS, RAC, Anna C. McFadden, PhD - Published 12 April 2016

This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events.

Categories: Features, Compliance, Crisis management, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: Risk management, Volkswagen, Defeat device,

Practical Guidance for Regulatory Professionals on Combination Products By Suzette Roan, JD, John Towns, PhD - Published 05 February 2016

This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, IMDRF, Combination products, Research and development, Submission and registration

Tags: Combination products, Design validation, Risk management, IMDRF

Woodcock: Drug Safety Surveillance System Ready for Full Operation By Michael Mezher - Published 03 February 2016

The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Sentinel, Mini-Sentinel, PRISM, BloodSCAN, Active Postmarket Risk Identification and Analysis, ARIA

EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions By Michael Mezher - Published 05 November 2015

After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used."

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Postmarket surveillance

Tags: Pharmacovigilance Risk Assessment Committee, PRAC, HPV vaccine, Gardasil, Cervarix, POTS, CRPS

FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration By Michael Mezher - Published 06 October 2015

The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems.

Categories: News, US, FDA, Blood, Drugs, Regulatory strategy

Tags: REMS, Risk evaluation and mitigation strategies, Structured product label, SPL

FDA’s Approach to Regulating Fitness Trackers Wins Industry Praise By Alexander Gaffney, RAC - Published 22 June 2015

Should "general wellness" products like weight management tools, fitness trackers or relaxation helpers be regulated as de facto medical devices? The US Food and Drug Administration (FDA) doesn't think so, much to the relief of manufacturers of general wellness products.

Categories: News, US, CDRH, Medical Devices

Tags: General Wellness Devices, Guidance, Draft Guidance, General Wellness: Policy for Low Risk Devices

FDA Unveils New Website Improvements to Help Industry Keep Track of REMS By Alexander Gaffney, RAC - Published 17 June 2015

The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US.

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

Tags: REMS, Risk Evaluation and Mitigation Strategies

BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA By Alexander Gaffney, RAC - Published 17 June 2015

Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues.

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

Tags: Patients, Patient Preference, Structured Benefit Risk Framework, Whitepaper, Patient Centered Drug Development

EU Committee Confirms Increased Risk with Ibuprofen at High Doses By Michael Mezher - Published 13 April 2015

A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: Ibuprofen, NSAIDs, PRAC, Pharmacovigilance Risk Assessment Committee

FDA Explains how Companies can Modify a Drug Safety Assurance Plan By Alexander Gaffney, RAC - Published 06 April 2015

A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling, Postmarket surveillance

Tags: REMS, Guidance, Final Guidance, Risk Evaluation and Mitigation Strategies, Prior Approval Supplement, CBE, Changes Being Effects, PAS

FDA Plans Huge Study on How Public Understands Drug Risk By Alexander Gaffney, RAC - Published 19 November 2014

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

Tags: OPDP, Study, Advertising, Drug Risk, Drug Benefit

In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims By Alexander Gaffney, RAC - Published 06 November 2014

The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny.

Categories: News, US, CDER, Advertising and Promotion, Drugs

Tags: Untitled Letter, OPDP, Unsubstantiated Claims, Risk Information, Office of Prescription Drug Promotion

Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved By Alexander Gaffney, RAC - Published 22 September 2014

A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market.

Categories: News, US, CDER, Biologics and biotechnology, Generic drugs, Prescription drugs, Regulatory strategy, Submission and registration

Tags: REMS, Fair Access for Safe and Timely (FAST) Generics Act, Legislation, Risk Evaluation and Mitigation Strategies

Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds By Alexander Gaffney, RAC - Published 24 July 2014

A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended.

Categories: News, US, CDER, Generic drugs, Submission and registration

Tags: REMS, Risk Evaluation and Mitigation Strategies, Study, GPhA, Generic Drug

After Quiet Quarter, OPDP Releases New Untitled Letter for Familiar Reasons By Alexander Gaffney, RAC - Published 15 May 2014

For the first time in nearly three months, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has released a new Untitled Letter, this time alleging that a company's printed sales aid is misleading in that it does not adequately communicate the risks of the product.

Categories: News, US, CDER, Compliance, Drugs, Labeling

Tags: OPDP, Untitled Letter, Misleading, Risk Omission, Omission of Risk

In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures By Alexander Gaffney, RAC - Published 13 March 2014

Categories: EMA

Tags: RMP, Risk Management Plan, Post-Authorization, Postmarketing, Public, Transparency, Latest News, EU

Company's Facebook Page Gets it in Trouble with FDA By Alexander Gaffney, RAC - Published 12 March 2014

Categories: US, FDA

Tags: Ommission of Risk, Misbranding, Tirosint, Facebook, Untitled Letter, Latest News

FDA Expresses Interest in Increasing Impact, Reach of Safety Warnings By Alexander Gaffney, RAC - Published 03 January 2014

Categories: US, FDA

Tags: RCAC, Communication, risk

A (Technologically Stunted) Ad/Promo Reviewer Looks at Techy Solutions to Regulatory Issues By Moulakshi Roychowdhury, PharmD, JD - Published 02 September 2013

Let's face it, regulatory advertising and promotion reviewers are generally not a technologically savvy demographic. Provided here is a brief review of three technology vendors that appear to provide optimal solutions to regulatory problems.

Categories: Features

Tags: adverse event tracker, risk information, software, technology