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.

Regulatory Recon: WHO Finds Evidence of Data Manipulation at Indian CRO (7 July 2015)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Orphan products, Clinical, Regulatory strategy, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports.

Categories: Biologics and biotechnology, Drugs, Distribution, Government affairs, Manufacturing, Regulatory strategy, News, India Tags: Compulsory license, saxagliptin, Lee Pharma, AstraZeneca
Regulatory Recon: Vertex' Orkambi Gets FDA Nod, Indication Covers Half of CF Patients (6 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
Public Health Advocates Worry EMA and Industry are Too Cozy

A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry.

Categories: Drugs, Ethics, Regulatory strategy, Submission and registration, News, Europe, EMA, EC Tags: Conflict of interest, Health Action Internationa, HAI, Fees
European Regulatory Roundup: Commission Under Fire for Delay in Implementing Falsified Medicines Legislation (2 July 2015)

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

Categories: Drugs, Medical Devices, Reimbursement, Regulatory strategy, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

Since 2007, the US Food and Drug Administration (FDA) has issued a small 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: Biologics and biotechnology, Drugs, Research and development, Regulatory strategy, Submission and registration, News, US, CDER 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
Regulatory Recon: A Changing of the Guard (2 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
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
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: News, Asia, Oceania, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
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
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
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