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.

EMA Lays out Plans for Companion Diagnostic Guideline

The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines.

Categories: In vitro diagnostics, News, Europe, EMA Tags: Companion Diagnostics, CDx, Precision Medicine, Biomarkers
TGA Consults on Biological Naming

Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems.

Categories: Biologics and biotechnology, News, Oceania, TGA Tags: Biological Naming, Biosimilars, INN, Nonproprietary Name, Suffix, Biological Qualifier
Regulatory Recon: Merck Says June Cyber Attack Led to Lower Guidance; Roche Leukemia Drug Picks Up Breakthrough Designation (28 July 2017)

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 Updates on Digital Health Plans, Software Pre-Certification Pilot

The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices.

Categories: Medical Devices, Submission and registration, News, US, CDRH Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health
Regulatory Recon: AstraZeneca Immunotherapy Fails in Lung Cancer Study; FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017)

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: EMA Adopts Revised First-in-Human Trial Guidance; UK Appoints Industry Veteran Ahead of Negotiations with Pharma (27 July 2017)

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

Categories: Biologics and biotechnology, Blood, Drugs, Veterinary products, Clinical, News, Europe, EMA, MHRA Tags: EU Regulatory Roundup, Regulatory Roundup
ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection.

Categories: Drugs, Clinical, News, FDA, ICH Tags: Safety Data, ICH, International Conference for Harmonization, E19
Regulatory Recon: Celgene to Pay $280M to Settle Off-Label Promotion Suit; GSK Calls for at Least Two-Years' Brexit Transition (26 July 2017)

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 Finalizes GDUFA Q&A Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues.

Categories: Generic drugs, Compliance, Submission and registration, News, US, FDA Tags: Guidance, GDUFA, Abbreviated New Drug Application, Self-Identification
Gottlieb: FDA Will Delay Sending Layoff Notices

In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then.

Categories: Government affairs, News, US, FDA Tags: User Fee Reauthorization, Layoffs, Reduction in Force, RIF, Scott Gottlieb
Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017)

India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Manufacturing, News, India, Oceania, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit; Stada Board Accepts Bain, Cinven's Latest Takeover Offer (25 July 2017)

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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 Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Ethics, News, US, FDA Tags: Informed Consent, Minimal Risk, 21st Century Cures
FDA Updates on Two ICH Guidelines

The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, News, US, FDA, ICH Tags: M4E(R2), Benefit-Risk Assessment, Efficacy, Q3C, Residual Solvents
Regulatory Recon: Mitsubishi Tanabe Buys NeruoDerm for $1.1B; FDA Reviewers Raise Concerns About Intelli's Long-Acting Opioid Ahead of Panel (24 July 2017)

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
EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda

The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, Europe, EMA Tags: CHMP
EMA Recommends Suspending Certain Gadolinium Contrast Agents

The European Medicines Agency (EMA) on Friday said it plans to suspend the marketing authorization for three gadolinium contrast agents and restrict the use of others after a review by the agency's Pharmacovigilance Risk Assessment Committee (PRAC) confirmed evidence of gadolinium accumulation in patients' brains months after being injected.

Categories: Drugs, News, Europe, EMA Tags: Gadolinium
Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Current Offices (21 July 2017)

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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 Clears First MRI Meant for Use in NICUs

The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs).

Categories: Medical Devices, News, FDA Tags: MRI, Magnetic Resonance Imaging, Embrace Neonatal MRI, NICU
CDRH Clarifies Process for Consensus Standard Recognition Requests

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act.

Categories: Medical Devices, News, US, FDA Tags: Consensus Standards, 21st Century Cures Act
European Regulatory Roundup: EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA (20 July 2017)

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

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration, News, Europe, EMA Tags: EU Regulatory Roundup
Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero; Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017)

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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 Warns Phototherapy Device Maker for Quality System Issues

The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March.

Categories: Medical Devices, News, US, FDA Tags: Warning Letter, National Biological Corporation
FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings

The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023.

Categories: Drugs, Distribution, Packaging, News, US, FDA Tags: DSCSA, Supply Chain
Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations; FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017)

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
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