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 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)

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 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
Senate Appropriations Bill Maintains FDA Funding for 2018

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: Government affairs, News, US, FDA Tags: Appropriations, FY2018, User Fees, Budget
Gottlieb: FDA to Issue new Policies to Streamline Generic Reviews in 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: Generic drugs, Submission and registration, News, US, FDA Tags: ANDAs, MAPP
Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (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: Biologics and biotechnology, Drugs, Medical Devices, News, China, India, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: FDA Approves Puma's Breast Cancer Drug Nerlynx; US Court Upholds Takeda Patent on Velcade (18 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
Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs.

Categories: News, US, FDA Tags: Recruitment, Hiring, Vacancies, User Fees
Regulatory Recon: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 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
Report Calls on FDA to Adopt New Standard for Reviewing Opioids

The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic.

Categories: Drugs, Clinical, Postmarket surveillance, Submission and registration, News, US, FDA Tags: Opioids, Opioid Epidemic
EMA Updates Guidance on Three Post-Authorisation Activities

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

Categories: Biologics and biotechnology, Drugs, Quality, Submission and registration, News, Europe, EMA Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation
Regulatory Recon: J&J Uses Priority Review Voucher to Speed Psoriasis Approval; DoJ Charges 412 in Healthcare, Opioid Schemes (14 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 Panel Unanimously Backs Avastin and Herceptin Biosimilars

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

Categories: Biologics and biotechnology, Submission and registration, News, US, FDA Tags: Avastin, Herceptin, Biosimilars, ADP 215, MYL-1401O
European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, NICE Tags: European Regulatory Roundup, Brexit, reimbursement
FDA: Lead Test Company May Have Violated Federal Law

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: In vitro diagnostics, News, US, CDRH Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483
FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances

The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies.

Categories: Generic drugs, Research and development, News, US, FDA Tags: bioequivalence guidance, FDA draft guidance
White House Doubles Down on Call to Fund FDA Entirely With Industry Fees

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Government affairs, News, US, FDA Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill
Regulatory Recon: Amgen's Blincyto Wins Full FDA Approval; NICE Backs Three Drugs for Plaque Psoriasis in Children (13 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 Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: Human cell and tissue, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC
House Passes Bill to Reauthorize FDA User Fee Programs

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA Tags: FDARA, FDA user fee reauthorization, user fees, BsUFA, MDUFA, GDUFA, PDUFA
FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Categories: Drugs, Postmarket surveillance, News, US, FDA Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis
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