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.

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Keytruda, Merck, biomarkers, oncology approvals
EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: Clinical, Compliance, Government affairs, Research and development, News, Europe, EMA Tags: clinical trial regulations, EMA guideline
Trump’s 2018 Budget Seeks Last-Minute Renegotiation of FDA User Fee Deals

President Donald Trump's FY 2018 budget proposal for the US Food and Drug Administration (FDA), leaked late Monday, seeks a last-minute renegotiation of user fee deals forged over the last two years to make up for about a 30% decrease in the agency’s budget.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA Tags: Trump budget, FY 2018 FDA budget
WHO Elects First African Director-General

The World Health Organization (WHO) on Tuesday announced that Dr. Tedros Adhanom Ghebreyesus of Ethiopia has been elected by member states as the new Director-General of WHO.

Categories: Government affairs, News, Africa, WHO Tags: Director-General WHO
Gottlieb Establishes FDA Committee to Confront Opioid Crisis

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

Categories: Drugs, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee
FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials.

Categories: Active pharmaceutical ingredients, Crisis management, Manufacturing, News, US, China, FDA Tags: FDA warning letters, China API manufacturers
Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, News, Asia, Oceania, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S
Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA, EC, Health Canada, TGA, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
New Indication for Roche’s Actemra Means First FDA-Approved Drug to Treat Giant Cell Arteritis

The US Food and Drug Administration (FDA) on Monday expanded the approved use of Roche’s Actemra (tocilizumab) to treat adults with giant cell arteritis, making it the first FDA-approved therapy for this condition.

Categories: Biologics and biotechnology, Government affairs, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Actemra, Roche, giant cell arteritis, monoclonal antibodies
Australia Considers Allowing the Marketing of Devices Approved Overseas

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, Oceania, TGA Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices
FDA to Drug Manufacturers: Beware Water-Borne Contaminants

With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose.

Categories: Crisis management, Manufacturing, News, US, FDA Tags: pharmaceutical contamination, FDA on contamination, BCC, water contaminants
EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders
Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Canada, Europe, Asia, Latin America and Caribbean, FDA, MHLW, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Details How Kalydeco's Indication Expanded Without New Clinical Data

For the first time, the US Food and Drug Administration (FDA) has expanded a drug's indication without additional clinical data.

Categories: Drugs, Regulatory strategy, Submission and registration, News, US, FDA Tags: Kalydeco, Cystic Fibrosis
Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.

Categories: Biologics and biotechnology, Drugs, Research and development, News, US Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi
EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA Tags: CHMP, Sanofi, Celltrion, XBiotech, Spherox
Regulatory Recon: House Committee Schedules FDA Budget Hearing; Janssen Sues to Block Samsung Bioepis' Remicade Biosimilar (19 May 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, Industry Look for Gaps in Cybersecurity

The US Food and Drug Administration (FDA) on Thursday kicked off a fortuitously-timed public workshop on medical device cybersecurity, the agency's third on the subject to date.

Categories: Medical Devices, News, US, CDRH Tags: Cybersecurity, WannaCry
Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, US, Canada, Europe, FDA, Health Canada Tags: ASCO, Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance
House Subcommittee Advances User Fee Reauthorizations

Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA Tags: E&C, FDA user fees, user fee reauthorization
European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA, EC Tags: European Regulatory Roundup, EU roundup of pharma news, Aspen, personalized medicine, ANSM
Petition to FDA Seeks to Modify Trial Regulations Following Deaths

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs).

Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, News, US, FDA Tags: citizen petition, FDA petition, clinical trial regulations
FDA Warns of False Results With Common Lead Test

In the wake of a lead contamination crisis affecting cities across the country, the US Food and Drug Administration (FDA) on Wednesday warned that a commonly used line of lead testing systems may provide falsely low results under certain circumstances.

Categories: In vitro diagnostics, Medical Devices, News, US, CDRH Tags: Lead, Magellan Diagnostics, LeadCare
Canada Proposes to Amend Drug Pricing Regulations

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: Biologics and biotechnology, Drugs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, Canada, FDA, NICE, Health Canada Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers
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