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Regulatory Recon: AstraZeneca Immunotherapy Fails in Lung Cancer Study; FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017) By Michael Mezher - Published 27 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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) By Nick Paul Taylor - Published 27 July 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Blood, Clinical, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup

FDA Updates on Digital Health Plans, Software Pre-Certification Pilot By Michael Mezher - Published 27 July 2017

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: News, US, CDRH, Medical Devices, Submission and registration

Tags: Pre-Certification, PreCert Pilot, Software as a Medical Device, SaMD, Digital Health

ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data By Michael Mezher - Published 26 July 2017

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: News, FDA, ICH, Clinical, Drugs

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) By Michael Mezher - Published 26 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit; Stada Board Accepts Bain, Cinven's Latest Takeover Offer (25 July 2017) By Michael Mezher - Published 25 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Gottlieb: FDA Will Delay Sending Layoff Notices By Michael Mezher - Published 25 July 2017

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: News, US, FDA, Government affairs

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) By Nick Paul Taylor - Published 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: News, India, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Finalizes GDUFA Q&A Guidance By Michael Mezher - Published 25 July 2017

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: News, US, FDA, Compliance, Generic drugs, Submission and registration

Tags: Guidance, GDUFA, Abbreviated New Drug Application, Self-Identification

FDA Updates on Two ICH Guidelines By Michael Mezher - Published 24 July 2017

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: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Submission and registration

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) By Michael Mezher - Published 24 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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 By Michael Mezher - Published 24 July 2017

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: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics, Medical Devices

Tags: Informed Consent, Minimal Risk, 21st Century Cures

EMA Recommends Suspending Certain Gadolinium Contrast Agents By Michael Mezher - Published 21 July 2017

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: News, Europe, EMA, Drugs

Tags: Gadolinium

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda By Michael Mezher - Published 21 July 2017

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: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: CHMP

Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Current Offices (21 July 2017) By Michael Mezher - Published 21 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Clears First MRI Meant for Use in NICUs By Michael Mezher - Published 20 July 2017

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: News, FDA, Medical Devices

Tags: MRI, Magnetic Resonance Imaging, Embrace Neonatal MRI, NICU

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) By Michael Mezher - Published 20 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

European Regulatory Roundup: EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA (20 July 2017) By Nick Paul Taylor - Published 20 July 2017

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

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: EU Regulatory Roundup

CDRH Clarifies Process for Consensus Standard Recognition Requests By Michael Mezher - Published 20 July 2017

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: News, US, FDA, Medical Devices

Tags: Consensus Standards, 21st Century Cures Act

FDA Warns Phototherapy Device Maker for Quality System Issues By Michael Mezher - Published 19 July 2017

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: News, US, FDA, Medical Devices

Tags: Warning Letter, National Biological Corporation

FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings By Michael Mezher - Published 19 July 2017

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: News, US, FDA, Distribution, Drugs, Packaging

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) By Michael Mezher - Published 19 July 2017

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

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Senate Appropriations Bill Maintains FDA Funding for 2018 By Michael Mezher - Published 18 July 2017

The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Government affairs

Tags: Appropriations, FY2018, User Fees, Budget

Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 2017 By Michael Mezher - Published 18 July 2017

By the end of 2017, the US Food and Drug Administration (FDA) will issue two new documents to improve the review process for generic drugs, according to FDA Commissioner Scott Gottlieb.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: ANDAs, MAPP

Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (18 July 2017) By Nick Paul Taylor - Published 18 July 2017

Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathways and other reforms will increase burdens while decreasing flexibility.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup