Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

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: Generic drugs, Regulatory strategy, News, US, CDER Tags: Bioequivalence, BE, ANDA, Bioequivalence Recommendations, Product-Specific BE Recommendations
India Takes Inspiration From FDA, EMA in Bid to Improve CDSCO

India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), might receive a major overhaul and a new name if a proposal by the Ministry of Health is enacted, Bloomberg TV India reports.

Categories: Drugs, Medical Devices, Clinical, Compliance, Government affairs, Manufacturing, Regulatory intelligence, News, India, CDSCO Tags: Central Drug Administration, CDA
FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

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Categories: Medical Devices, News, US, CDRH Tags: Surgical Gown, PPE, Personal Protective Equipment, Surgical Apparel, Draft Guidance, Guidance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)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
European Commission Says Compulsory Licensing can Only Happen at National Level

After being questioned by a member of the European Parliament, the European Commission (EC) says neither it nor the European Medicines Agency (EMA) have the power to acquire patents or issue a compulsory license.

Categories: Drugs, Government affairs, Reimbursement, News, Europe, EMA, EC Tags: Hepatitis C, HCV, Gilead, Sovaldi, Harvoni, Compulsory license, TRIPS
FDA Dials in on MRI Safety of Passive Implantable Medical Devices

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: Medical Devices, Research and development, News, US, CDRH Tags: Draft Guidance, Guidance, MRI, Passive Device
Regulatory Recon: EMA Recommends 10 New Drugs for Approval (26 June 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
French Regulator and Roche Trade Blows Over Off-Label Avastin Use

On Monday, Swiss drugmaker Roche announced its opposition to the use of its cancer drug Avastin to treat wet age-related macular degeneration (AMD) in France. The move is aimed squarely at France's drug regulator, who temporarily recommended the drug for AMD as a cost saving maneuver in April 2015.

Categories: Biologics and biotechnology, Labeling, Submission and registration, News, Europe Tags: France, ANSM, Roche, Avastin, Lucentis, Wet AMD
European Regulatory Roundup: EU Court Rescinds Drug Approval Over Dispute (25 June 2015)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Regulatory intelligence, News, Europe, EMA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
FDA Explains How Medical Device Companies Can Comply With UDI Marking Requirements

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: Medical Devices, Labeling, News, US, CDRH Tags: UDI, Unique Device Identification, Draft Guidance, Guidance, Marking, UDI Marking
India Says Other Regulators Will Have Access to Export Database

India is planning to make a database used to track drug exports available to regulators and companies around the world, The Economic Times reports.

Categories: Drugs, Labeling, Quality, News, India, CDSCO Tags: Track and Trace, Spurious drugs
Regulatory Recon: Controversial Contraceptive Device Essure Under FDA Scrutiny (25 June 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

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: Biologics and biotechnology, Drugs, News, US, CDER, Advertising and Promotion Tags: DTC, Direct-to-Consumer Advertising, Study, Hearing, Elderly
FDA Finalizes Guidance on Overfilling Injectable Vials

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: Biologics and biotechnology, Drugs, News, US, CBER, CDER Tags: Vials, Guidance, Final Guidance, Overfill
'Right to Try' Legislation Tracker

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: Clinical, Ethics, Government affairs, News, US, CDER Tags: Right to Try, Right-to-Try, Compassionate Use, Expanded Access
Regulatory Recon: ‘Cures’ Bill to Give Small Percentage of Drugs Added Exclusivity (24 June 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Asia Regulatory Roundup: Indian Struggles With Regulatory Staffing Issues (23 June 2015)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Regulatory intelligence, News, Asia, CDSCO Tags: Regulatory Roundup, Asia Regulatory Roundup
Spider Catches Drug Company in Web of Deceit

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: Drugs, Audit, Compliance, News, US, CDER Tags: Spider, Warning Letter
Keeping an Eye on Corporate Integrity Agreements

Even in the world of healthcare product regulation, the initials CIA still stand for surveillance and vigilance.

Categories: Compliance, Ethics, Regulatory strategy, News, US, FDA, DOJ Tags: CIA, Corporate Integrity Agreement, RIQ, Graematter, Regulatory Intelligence Quotient
Regulatory Recon: Medicines Co. Snags Long-Sought Approval for Cangrelor (23 June 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
A Step Forward for New EU Medical Device Legislation

After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation.

Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, Regulatory strategy, Submission and registration, News, Europe, EC Tags: European Council, EPSCO Council, notified bodies, clinical investigation
FDA’s Approach to Regulating Fitness Trackers Wins Industry Praise

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: Medical Devices, News, US, CDRH Tags: General Wellness Devices, Guidance, Draft Guidance, General Wellness: Policy for Low Risk Devices
NIH Plots out Path Forward After Disastrous FDA Inspection

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.

Categories: Tags: NIH, National Institutes of Health, Pharmaceutical Development Section, PDS, Corrective Action Plan
Regulatory Recon: Will FDA Have Enough Money to Hire the Staff it Needs? (22 June 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
European Regulatory Roundup: EU Device Plan Advances (19 June 2015)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Regulatory intelligence, News, Europe, EMA, EC Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
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