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.

House Committee Probes Restricted Distribution Systems Delaying Generics

The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.

Categories: Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies
CDRH Seeks Participants for Staff Training Program

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

Categories: Combination products, In vitro diagnostics, Medical Devices, News, US, CDRH Tags: ELP, CDRH training, staff training FDA devices
Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration, News, Europe, EMA, EC Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel
EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO

The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.

Categories: Generic drugs, Compliance, Product withdrawl and retirement, Research and development, News, Europe, EMA, EC Tags: Indian CRO, CRO suspension, EMA suspension, generic drugs
Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 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 Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

Categories: Drugs, Clinical, Regulatory strategy, News, US, FDA Tags: Delayed Graft Function, DGF, Draft Guidance
MHRA Details Common Issues in Clinical Trial Applications

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays.

Categories: Biologics and biotechnology, Drugs, Clinical, News, Europe, MHRA Tags: Clinical Trial Applications, Validation
European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017)

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

Categories: Biologics and biotechnology, Drugs, Veterinary products, Reimbursement, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 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 Seeks Experts on Clinical Data Anonymization

The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, News, Europe, EMA Tags: Clinical Study Reports, Publication, Transparency, Anonymization
Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA Tags: PDUFA VI, Prescription Drug User Fee Act
Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease; Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 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 Two Drugmakers in China and India for Data Integrity Violations

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: Drugs, Compliance, Manufacturing, News, US, China, India, FDA, APIs Tags: Data Integrity
FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: Medical Devices, Compliance, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA, TGA, WHO Tags: breast implants, lymphoma, BIA-ALCL
Maryland House Passes Bill on Price Gouging of Generic Drugs

Late Monday, Maryland’s House of Delegates signed off on a bill seeking to prohibit companies from overcharging for generic drugs.

Categories: Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US Tags: price gouging, pharmaceutical price legislation, Maryland drug price gouging
CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, CBER, CDER, CDRH Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP
Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee; Amgen Submits Herceptin Biosimilar for EU Approval (21 March 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
Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, News, Asia, CDSCO, TGA Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance
FDA Approved Nearly All Expanded Access Requests in FY2016

The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week.

Categories: Biologics and biotechnology, Drugs, Clinical, Ethics, News, US, FDA Tags: Expanded Access, Compassionate Use, Right-To-Try
FDA Offers 2016 Report on Medical Countermeasure Activities

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: Biologics and biotechnology, Government affairs, Quality, News, US, FDA Tags: medical countermeasures, Ebola, Zika, flu vaccine
Humacyte Receives First of FDA’s Regenerative Medicine Designations

The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CBER Tags: RMAT designation, regenerative medicine, 21st Century Cures
Regulatory Recon: China Looks to Speed Approvals for Imported Drugs; Highlights from ACC17 (20 March 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
Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

Categories: Drugs, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports
FDA Delays Final Rule on Intended Uses

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA, Communication Tags: Intended Use, Final Rule, Totality of Evidence
Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency

At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, US, FDA Tags: Cummings, Sanders, drug prices, PBMs
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