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.

European Commission to Overhaul Concept of ‘Similar’ Medicines Within Context of Orphan Legislation

The European Commission on Friday proposed to review the concept of “similar medicinal products” in the context of its orphan legislation as part of a wider effort to adapt the text to technical progress.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Orphan products, Government affairs, News, Europe, EC Tags: orphan drug legislation, European Commission, gene therapy, ATMP
EMA to Cut One Drug Division, Strengthen Collaborations With National Competent Authorities

As the European Medicine Agency (EMA) prepares to relocate its headquarters from London, thanks to the Brexit vote, the agency is also restructuring as part of what it says will be a leaner, more streamlined architecture that builds on the overhaul from 2013 and 2014.

Categories: Drugs, Government affairs, News, Europe, EMA Tags: EMA and Brexit, Brexit, EMA in London
EMA Offers First Guidance Devoted Entirely to PBPK Modelling

The European Medicines Agency (EMA) on Friday unveiled its first-ever draft guideline focused on the use of physiologically-based pharmacokinetic (PBPK) modelling.

Categories: Preclinical, Research and development, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: PBPK modelling, EMA guidance, MAA dossier
Regulatory Focus Features Recap: July 2016

Feature articles for July focused on managing regulatory information and systems and eCTD submissions.

Categories: Submission and registration, Features Tags: Features Recap, Regulatory Focus, eCTD, Electronic Common Technical Document
Regulatory Recon: US, UK Launch New Partnership for Antibiotic Development; Abbott Wants Out of Alere Deal (29 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Declares ‘General Wellness’ Devices Exempt From Regulations

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: Medical Devices, Government affairs, Postmarket surveillance, Submission and registration, News, US, FDA Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA
Democrats Tell FDA, CMS to Hand Over Theranos Data

A group of high-ranking Democrats sent letters to the heads of the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) this week asking them to turn over data from their investigations of blood testing startup Theranos.

Categories: In vitro diagnostics, Government affairs, News, US, FDA Tags: Theranos
Medical Device Companies to See Slight Discount in FDA User Fees in 2017

Medical device companies will see a modest decrease in application fees for FY 2017 when compared to 2016, according to new rates released Thursday by the US Food and Drug Administration (FDA).

Categories: Medical Devices, Compliance, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: MDUFA, medical device user fees
European Regulatory Roundup: Sandoz, Sanofi and Teva Drugs Face Suspension After EMA Faults Bioequivalence Tests (28 July 2016)

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

Categories: Drugs, Medical Devices, Clinical, Crisis management, Government affairs, Manufacturing, Quality, News, Europe, EMA, MHRA Tags: European Regulatory Roundup, EU drug and device news
Regulatory Recon: Sanofi's Adlyxin Approved for Type 2 Diabetes; PhRMA, BIO Release Off-Label Communications Principles (28 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: Generic drugs, Crisis management, Manufacturing, Project management, News, US, FTC Tags: Teva, Allergan, generic drugs, generic drug competition
EMA Adds Four New Drugs to PRIME Scheme

The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, Research and development, Regulatory strategy, Submission and registration, News, Europe, EMA Tags: PRIME scheme, PRIority MEdicines, Novartis, Merck, Adaptimmune, DNATrix, CTL019, Ebola Vaccine, NY-ESO-1c259T, DNX-2401
Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000.

Categories: Biologics and biotechnology, Drugs, Compliance, Research and development, Submission and registration, News, US, FDA Tags: PDUFA user fee, BsUFA user fee, new drug fees, FDA user fees, 2017 industry fees to FDA
Regulatory Recon: TauRX Alzheimer's Drug Fails in Phase III; GSK to Invest £275m in UK Manufacturing Sites (27 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Finalizes Guidance on Adaptive Designs for Device Studies

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

Categories: Medical Devices, Due Diligence, Research and development, News, US, FDA Tags: adaptive trial designs, device clinical trials, final FDA guidance
FDA to Reevaluate Gay Blood Donor Guidance

The US Food and Drug Administration (FDA) on Tuesday called for public input on its December 2015 guidance that ended the agency's indefinite ban on gay men donating blood in favor of a 12-month deferral since the donor last had sex with another man.

Categories: Blood, News, US, FDA Tags:
FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions.

Categories: Medical Devices, Clinical, Government affairs, Postmarket surveillance, Preclinical, Research and development, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: real-world data, device and real world evidence, device registries, FDA guidance on real world data
MHRA Drops Pharmacovigilance Compliance Reporting Requirements

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) says it no longer wants drugmakers to submit regular drug safety surveillance compliance reports, unless they are specifically requested by the agency.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, Europe, MHRA Tags: Pharmacovigilance, GPvP, GVP
FDA Lowers ANDA Fee Rates for 2017

Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.

Categories: Active pharmaceutical ingredients, Generic drugs, Compliance, Government affairs, Manufacturing, Preclinical, Project management, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: generic drug API manufacturing, GDUFA, generic drug facility fees, FDA fees
Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016)

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

Categories: Biologics and biotechnology, Drugs, Ethics, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA, Business and Leadership Tags: CDSCO, stent prices, vaccine storage, Indonesia vaccines
Regulatory Recon: Baxter, Lilly Beat Sales Estimates; Gilead Lowers Guidance Amid Lower HCV Sales (26 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
UDI Form and Content: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Monday released new draft guidance to help define the expected content and forms of the Unique Device Identifier (UDI), to assist both medical device labelers and FDA-accredited issuing agencies in ensuring that UDIs are in compliance with the UDI Rule.

Categories: Medical Devices, Labeling, Postmarket surveillance, Submission and registration, News, US, FDA, Business and Leadership Tags: unique device identifier, UDI, UDI guidance, FDA draft guidance
FDA Continues Steady Reduction of Generic Drug Application Backlog

As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs).

Categories: Generic drugs, Crisis management, Due Diligence, Government affairs, Manufacturing, News, US, FDA Tags: ANDA backlog, generic drug approval, Woodcock, JAMA
FDA Sends Untitled Letter to Danish Drugmaker Over GMP Issues

The US Food and Drug Administration (FDA) has issued an untitled letter to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility.

Categories: Biologics and biotechnology, Manufacturing, Quality, News, US, Europe, CBER Tags: ALK-Abelló, Untitled Letter, Pharmalgen
Regulatory Recon: FDA Panel Split Over Alere Diabetes Diagnostic; EMA Recommends Suspending Drugs Over Data Integrity Issues at Semler (25 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
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