Search Results for Alexander Gaffney

Showing 1 – 25  of 3876

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

Regulatory Recon: A Changing of the Guard (2 July 2015) By Alexander Gaffney, RAC - Published 02 July 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Patient-Focused Drug Development Tracker By Alexander Gaffney, RAC - Published 01 July 2015

The US Food and Drug Administration's patient-focused drug development program is poised to overhaul how drugs are approved for rare and inadequately served diseases and conditions. This tracker provides an in-depth look at what questions FDA is asking of patients and their representatives.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD

Regulatory Recon: WHO Weighs in on Biosimilar Naming (1 July 2015) By Alexander Gaffney, RAC - Published 01 July 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program By Alexander Gaffney, RAC - Published 01 July 2015

The US Food and Drug Administration (FDA) has released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development (PFDD) program—an integral part of the most recent authorization of the Prescription Drug User Fee Act (PDUFA).

Categories: News, US, CDER

Tags: PFDD, Patient-Focused Drug Development

Regulatory Recon: FDA Sued by Groups Seeking Access to Clinical Trials Data (30 June 2015) By Alexander Gaffney, RAC - Published 30 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Exempts 120 Medical Device Types from Most Regulation By Alexander Gaffney, RAC - Published 30 June 2015

The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: 510(k), Premarket Notification, Exempt, Exemption

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi By Alexander Gaffney, RAC - Published 29 June 2015

A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir).

Categories: News, US, CDER, Generic drugs, Regulatory strategy

Tags: Bioequivalence, BE, ANDA, Bioequivalence Recommendations, Product-Specific BE Recommendations

FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance By Alexander Gaffney, RAC - Published 29 June 2015

It is an iconic image replicated during almost every single infectious disease outbreak in the last century: men and women clad head to toe in surgical gowns and surgical masks, tending to the sick or working to disinfect contaminated areas. But iconic or not, the US Food and Drug Administration (FDA) has a more pressing concern: Are the gowns effective at protecting their users from the spread of infection?

Categories: News, US, CDRH, Medical Devices

Tags: Surgical Gown, PPE, Personal Protective Equipment, Surgical Apparel, Draft Guidance, Guidance

Regulatory Recon: Jail Time for Former Medical Device CEO Over Regulatory Infractions (29 June 2015) By Alexander Gaffney, RAC - Published 29 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: EMA Recommends 10 New Drugs for Approval (26 June 2015) By Alexander Gaffney, RAC - Published 26 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Dials in on MRI Safety of Passive Implantable Medical Devices By Alexander Gaffney, RAC - Published 26 June 2015

For the second time in a year, the US Food and Drug Administration (FDA) has released new guidance intended to ensure the safety of implanted medical devices from magnetic resonance imaging (MRI) devices.

Categories: News, US, CDRH, Medical Devices, Research and development

Tags: Draft Guidance, Guidance, MRI, Passive Device

FDA Explains How Medical Device Companies Can Comply With UDI Marking Requirements By Alexander Gaffney, RAC - Published 25 June 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify the process of "marking" a medical device with a Unique Device Identifier (UDI).

Categories: News, US, CDRH, Labeling, Medical Devices

Tags: UDI, Unique Device Identification, Draft Guidance, Guidance, Marking, UDI Marking

Regulatory Recon: Controversial Contraceptive Device Essure Under FDA Scrutiny (25 June 2015) By Alexander Gaffney, RAC - Published 25 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

'Right to Try' Legislation Tracker By Alexander Gaffney, RAC - Published 24 June 2015

Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.

Categories: News, US, CDER, Clinical, Ethics, Government affairs

Tags: Right to Try, Right-to-Try, Compassionate Use, Expanded Access

What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding By Alexander Gaffney, RAC - Published 24 June 2015

The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising.

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

Tags: DTC, Direct-to-Consumer Advertising, Study, Hearing, Elderly

FDA Finalizes Guidance on Overfilling Injectable Vials By Alexander Gaffney, RAC - Published 24 June 2015

New guidance just issued by the US Food and Drug Administration (FDA) calls on pharmaceutical and biopharmaceutical companies to more closely control the amount of excess product contained in vials of injectable drugs and biologics.

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

Tags: Vials, Guidance, Final Guidance, Overfill

Regulatory Recon: ‘Cures’ Bill to Give Small Percentage of Drugs Added Exclusivity (24 June 2015) By Alexander Gaffney, RAC - Published 24 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Spider Catches Drug Company in Web of Deceit By Alexander Gaffney, RAC - Published 23 June 2015

Some Warning Letters sent by the US Food and Drug Administration (FDA) to pharmaceutical companies are destined to become case studies, either because of the novelty of the agency's arguments or the scope or context of the alleged violation.

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

Tags: Spider, Warning Letter

Regulatory Recon: Medicines Co. Snags Long-Sought Approval for Cangrelor (23 June 2015) By Alexander Gaffney, RAC - Published 23 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Will FDA Have Enough Money to Hire the Staff it Needs? (22 June 2015) By Alexander Gaffney, RAC - Published 22 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

NIH Plots out Path Forward After Disastrous FDA Inspection By Alexander Gaffney, RAC - Published 22 June 2015

The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities.

Tags: NIH, National Institutes of Health, Pharmaceutical Development Section, PDS, Corrective Action Plan

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 to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically By Alexander Gaffney, RAC - Published 19 June 2015

The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically.

Categories: News, US, CDRH, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: eMDR, MDR, Adverse Events, 3500A, Final Rule, Medical Device Reporting

Regulatory Recon: China Rejects Gilead Patent on Sovaldi Prodrug (19 June 2015) By Alexander Gaffney, RAC - Published 19 June 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News