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.

Electronic Application Forms Mandatory for EU Centralized Procedure

Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure.

Categories: Biologics and biotechnology, Drugs, Veterinary products, Submission and registration, News, Europe, EMA Tags: Electronic application forms, eAF, eSubmission
FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program

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
Patient-Focused Drug Development Tracker

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: Biologics and biotechnology, Drugs, Orphan products, News, US, CBER, CDER Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD
FDA Advisory Committee Calendar

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: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees
Regulatory Recon: WHO Weighs in on Biosimilar Naming (1 July 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
FDA Exempts 120 Medical Device Types from Most Regulation

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: Medical Devices, Submission and registration, News, US, CDRH Tags: 510(k), Premarket Notification, Exempt, Exemption
Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues

After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Distribution, Manufacturing, News, Canada, Europe, EMA, Health Canada Tags: Good manufacturing practice, GMP, EudraGMDP, Polydrug
FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements

The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA).

Categories: Biologics and biotechnology, Drugs, Distribution, News, US, CDER Tags: Track and Trace, DQSA, DSCSA, Guidance, Draft Guidance
Asia Regulatory Roundup: Australia Looks at New Regulatory Pathways (30 June 2015)

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

Categories: Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: FDA Sued by Groups Seeking Access to Clinical Trials Data (30 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
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
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