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 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The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing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
Regulatory Recon: Theranos Brings in New Regulatory, Compliance Execs; Valeant Gets CRL for Glaucoma Drug Over GMP Issues at Manufacturer (22 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
EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016

The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized.

Categories: Biologics and biotechnology, Clinical, Preclinical, News, Europe, EMA, EC Tags: First-in-Human, Phase I, Clinical Trials
European Regulatory Roundup: Novartis Faces MHRA Criticism on Trial Data Access (21 July 2016)

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

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, Novartis, adverse events
Regulatory Recon: Novartis CEO Predicts US Drug Pricing Overhaul; Chinese Scientists to Launch First Human CRISPR Trial (21 July 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, FDA, EMA, EC, MHRA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Warns GSK’s UK Site for Contamination in API Manufacturing

The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site.

Categories: Active pharmaceutical ingredients, Manufacturing, News, US, Europe, FDA Tags: GSK, penicillin, API manufacturing
Asia Regulatory Roundup: Indonesia to Overhaul Drug Regulator (20 July 2016)

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

Categories: Drugs, News, Asia, CFDA, CDSCO Tags: Asia Regulatory Roundup
Regulatory Recon: Zika Case in Florida Could be First Locally Acquired Case (20 July 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, FDA, EMA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Regulatory Recon: Novartis Gets Complete Response Letter for Neulasta Biosimilar; UK's First Minister of Life Sciences Moves On, Future of Office in Question (19 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
Regulatory Recon: FDA Approves First Extended Depth Lenses for People With Cataracts (18 July 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, Europe, Asia, FDA, EC, Health Canada, CDSCO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
The Next PDUFA: New Performance and Procedural Goals

Exactly one year after the first round of negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA), the US Food and Drug Administration (FDA) on Friday released the full details of the performance and procedural goals for fiscal years 2018 through 2022.

Categories: Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA, Business and Leadership Tags: PDUFA VI, FDA user fees, FDA performance goals 2016
European Commission Pushes for Closer Convergence With US on Device Regulations

As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations.

Categories: Medical Devices, Government affairs, News, US, Europe, FDA, EC Tags: UDIs, device regulations, medical devices in EU and US, TTIP
Regulatory Recon: Congress Takes Summer Vacation Without Addressing Zika (15 July 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Canada, Europe, Asia, FDA, EMA, EC, Health Canada, CFDA, TGA, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
ICER to Re-Evaluate How to Assess Value and Comparative Clinical Effectiveness

The Institute for Clinical and Economic Review (ICER), an independent nonprofit research institute, on Thursday opened a national call for suggestions on how to improve its value assessment framework, which assesses the comparative clinical effectiveness and value of health care tests, treatments and delivery systems.

Categories: Drugs, Reimbursement, News, US Tags: ICER, comparative effectiveness, evaluating drug costs
House E&C Committee Clears New Priority Review Voucher Program

The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, US, FDA Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews
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