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.

The Case for Sharing Private Drug and Device Data

A new report published by Georgetown University with support from a US Food and Drug Administration (FDA)-funded project calls for wider sharing of regulatory data in the hopes of enhancing the development of new products.

Categories: Clinical, Research and development, News, US Tags: Data Transparency, Regulatory Data, Clinical Trials Data, Report
Regulatory Recon: First US Vaccine for Meningitis B Approved (30 October 2014)

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 Finalizes Major Guideline on Biosimilars

The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU.

Categories: Biologics and biotechnology, Clinical, Preclinical, Submission and registration, News, Europe, EMA Tags: Biosimilars, Guideline, Biosimilarity, Stepwise Approach, Biosimilar Bridging Data
India’s CDSCO Reduces API Stability Testing Data Requirement

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three batches. 

Categories: Active pharmaceutical ingredients, Drugs, News, India, CDSCO, APIs Tags: Stability Testing, Accelerated Stability Data
Swiss Regulators Approve Ebola Vaccine Trial Meant to Protect Medical Volunteers

Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014.

Categories: Clinical, News, Europe Tags: Ebola, Swissmedic, World Health Organization, WHO
How NIH Hopes to Make Running Global Clinical Trials Easier for Everyone

The National Institutes of Health (NIH) has launched a new website meant to make complying with clinical trial regulations around the world substantially easier.

Categories: Biologics and biotechnology, Drugs, Clinical, Compliance, News, FDA, MHRA, CFDA, CDSCO Tags: ClinRegs, NIH, NIAID, Clinical Trials
Regulatory Recon: What Ever Happened to that Vial of Smallpox FDA Found? (29 October 2014)

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
Senators Call for Expansion of FDA Program to Help Fight Ebola

Bipartisan members of the US Senate's healthcare oversight committee plan to introduce legislation that would amend a little-used regulatory program in the hopes of spurring the development of treatments for the Ebola virus.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, News, US, FDA Tags: Ebola, Voucher, Priority Review Voucher, Senate, Legislation
FDA Wants Input on How to Improve Clinical Trials Process for Industry

The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, CDER, Communication Tags: IND, Communication, Guidance, PDUFA
FDA Hits Company for Improper Marketing on Facebook

The US Food and Drug Administration (FDA) has sent a new Warning Letter to a company regarding claims it made on Facebook, which the agency alleges violate federal law.

Categories: Nutritional and dietary supplements, News, US, FDA, Advertising and Promotion Tags: Facebook, Warning Letter
Regulatory Recon: FDA Effort to Block Counterfeit Drug Sales Runs Into Problems (28 October 2014)

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
Australian Government Orders Review of Drug and Device Regulations

The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices.

Categories: Drugs, Medical Devices, News, Oceania, TGA Tags: TGA, Australia
Company, Warned by FDA Over Improper Marketing, Petitions Regulators for Redress

Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation.

Categories: Nutritional and dietary supplements, News, US, FDA, Advertising and Promotion Tags: Citizen Petition, Warning Letter, Ebola
FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests

The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time.

Categories: In vitro diagnostics, Labeling, News, US, FDA Tags: Ebola, EUA, Emergency Use Authorization, BioFire Defense, Diagnostic, IVD
FDA Advisory Committee Calendar

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees
Regulatory Recon: Report Shows the Downsides to FDA's Surrogate Approvals (27 October 2014)

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 Outlines Regulatory Exemptions for Use of Cell, Tissue Products

A new guidance document issued by the US Food and Drug Administration (FDA) is trying to clarify the differences between tissue products and procedures which fall under the agency's regulations, and those products and procedures which do not.

Categories: Human cell and tissue, Submission and registration, News, US, CBER Tags: HCT/P, Cell, Tissue, Tissue-Based Products, Guidance, Draft Guidance
Regulatory Recon: WHO Seeking New Policy on Clinical Trials Data Transparency (24 October 2014)

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
Europe Establishes Roadmap for Companies Hoping to Get Ebola Treatments Approved

The European Medicines Agency (EMA)—Europe's equivalent to the US Food and Drug Administration (FDA)—says it stands ready, willing and able to help accelerate the evaluation of new medicines and vaccines meant to treat a global outbreak of the Ebola virus.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, Europe, EMA Tags: Ebola, Regulation of Ebola, EMA Ebola, Treatments for Ebola
FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds

A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, US, CDRH Tags: PMA, 510(k), De Novo, Review Times, Review Cohort, Medical Device Approvals
Regulatory Recon: EU to Keep Pharma, Device Industries Under DG Sanco (23 October 2014)

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
Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, Oceania, TGA Tags: CE Marking, Tony Abbott
CDSCO Forms Task Force Focused on User-Friendly Reforms

India’s Central Drugs Standard Control Organization (CDSCO) has announced the formation of a new task force to undertake a comprehensive review of the existing processes, procedures, forms and licenses used by the agency with the purpose of making them simpler and more user friendly.

Categories: Biologics and biotechnology, Drugs, News, India, CDSCO Tags:
Federal Audit Finds FDA Website, Internal Network Vulnerable to Hackers

A government audit of the US Food and Drug Administration (FDA), ordered last year after one of the agency's databases was compromised, has found the agency is vulnerable to hacking attempts which could lead to the loss of sensitive information.

Categories: News, US, FDA Tags: Hacking, FDA Hacked, Report, OIG, DHHS,
Headache Helper: FDA Outlines New Recommendations for Approving Migraine Therapies

The US Food and Drug Administration (FDA) is calling for a new approach in the way companies develop drugs intended to treat active migraines, a type of severe, long-lasting headache often characterized by a patient's sensitivity to light and sound.

Categories: Drugs, Clinical, News, US, CDER Tags: Migraine, Guidance, Draft Guidance
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