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.

European Medicines Regulators Put New Conflict-of-Interest Policy in Place

The European Medicines Agency (EMA) has released a new conflict-of-interest policy it says is meant to take a more "balanced" approach to handling conflicts presented by its scientific committee members and experts it consults with.

Categories: Biologics and biotechnology, Drugs, Ethics, News, Europe, EMA Tags: Conflict of Interest, COI
European Regulatory Roundup: Andreas Pott Takes Over at EMA (20 November 2014)

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

Categories: Regulatory intelligence, News, Europe, EMA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Pacemakers Get Hacked On TV, But Could It Happen In Real Life?

Jay Radcliffe breaks into medical devices for a living, testing for vulnerabilities as a security researcher.

Categories: Medical Devices, News, US, CDRH Tags: Medical Device Hacking, Medical Device Cybersecurity, Cybersecurity
FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.

Categories: Medical Devices, Compliance, Labeling, News, US, CDRH Tags: UDI, Unique Device Identification, Unique Device Identifier, UDI Marking, UDI Labeling, Device Implant
US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, News, US, FDA Tags: PRV, Priority Review Voucher, Congress, Adding Ebola to the FDA Priority Review Voucher Program Act, Ebola, Neglected Tropical Disease Priority Review Voucher
Oceania Regulator ANZTPA Shut Down by Australia and New Zealand

Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency (ANZTPA), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries.

Categories: Drugs, Medical Devices, News, Oceania, TGA, Medsafe, ANZTPA Tags: ANZTPA, TGA, Medsafe, ANZTPA Cancelled, Australia, New Zealand
Regulatory Recon: UK Looking at How to Speed up Drug Reimbursement Decisions (20 November 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
New FDA Guidance Explains Approval Process for HIV Prevention Products

New final guidance issued this week by the US Food and Drug Administration (FDA) is meant to clarify the development pathway for vaginal microbicides intended to prevent the transmission of the human immunodeficiency virus (HIV).

Categories: Biologics and biotechnology, Combination products, Drugs, Clinical, Preclinical, News, US, FDA Tags: HIV, Guidance, Final Guidance, Vaginal Microbicides
Laws Spreading That Allow Terminal Patients Access to Experimental Drugs

Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year.

Categories: Clinical, Ethics, News, US, FDA Tags: Right-to-Try, Compassionate Use, Expanded Access, Kaiser Health news
FDA Plans Huge Study on How Public Understands Drug Risk

Categories: Biologics and biotechnology, Drugs, News, US, CDER, Advertising and Promotion Tags: OPDP, Study, Advertising, Drug Risk, Drug Benefit
Proposed Rule Calls for Clinical Trial Results to be Reported, Even When Product Isn't Approved

The US Department of Health and Human Services (DHHS) today unveiled new proposed requirements for its online clinical trials register, ClinicalTrials.gov, that will require pharmaceutical and medical device companies to submit more information regarding patient enrollment, the progress of trials and the results of those trials--even when a product is never approved in the US.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, News, US, FDA Tags: ClinicalTrials.gov, Clinical Trials, Clinical Trials Reporting
Company's Compassion Leads to Clinical Hold on Experimental Drug

If you're trying to understand why some drug companies are reluctant to allow desperate patients to enroll in their early-stage clinical trials, look no further than the case of CytRx Corporation, whose clinical trial for the drug compound aldoxorubic is now partially on hold following the death of a patient enrolled in the trial on a compassionate use basis.

Categories: Clinical, News, US, CDER Tags: Compassionate Use, Expanded Access, Clinical Hold
Gilead Makes Record-Setting Purchase of Special FDA Voucher

The Canadian pharmaceutical company Knight Therapeutics has reportedly sold its Neglected Tropical Disease Priority Review Voucher to Gilead Sciences, making it the first time a tropical voucher has ever been sold.

Categories: Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration, News, US, CDER Tags: Tropical Disease Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Gilead, Knight Therapeutics, Priority Review Voucher, Voucher Sold
Regulatory Recon: $2.6 Billion to Get a Drug Approved, Study Finds (19 November 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
How Should FDA Prioritize the Review of Important New Generic Drugs? Agency Wants to Know

How should the US Food and Drug Administration (FDA) define the term "first-to-file" when it comes to approving new generic drug products? While the question seems small, at stake is nothing less than potentially billions in savings for consumers and the US government.

Categories: Generic drugs, Regulatory strategy, Submission and registration, News, US, CDER Tags: ANDA, First-to-File, 180-Day Exclusivity, First Generic, GDUFA, GDUFA Commitment Letter
ANVISA to Allow Medical Device Firms to Evaluate Their Inspections

Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.

Categories: Medical Devices, Quality, News, Latin America and Caribbean, Anvisa Tags: Emergo Group, Brazil, Quality Management, Brazilian GMP
Asia Regulatory Roundup: India's New Labeling Rule, China Set to Allow Inspectors (18 November 2014)

Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein.

Categories: Regulatory intelligence, News, Japan, China, India, Oceania, PMDA, CFDA, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works

The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works.

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags: Rare Pediatric Disease Priority Review Voucher, FDASIA, Voucher, Rare Pediatric Disease Voucher, Priority Review Voucher, Guidance, Draft Guidance
FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking.

Categories: Generic drugs, Regulatory strategy, Submission and registration, News, US, CDER Tags: ANDA, Abbreviated New Drug Application, 505(b)(2) Application, 505(q) Petition, Citizen Petition
Regulatory Recon: FDA Delays Release of Generic Drug Labeling Rule (18 November 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
Canada Launches Ebola Vaccine Trial

The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week. 

Categories: Biologics and biotechnology, Clinical, News, Canada, Health Canada Tags: RegLink, CIRN, Ebola, Vaccine, Ebola Vaccine, Canadian Institutes of Health Research, Public Health Agency of Canada
New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

Health Canada, Canada’s medical device market regulator, has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications.

Categories: Medical Devices, Submission and registration, News, Canada, Health Canada Tags: Emergo Group, MDL, Medical Device License, Class III MDL Application, Class IV MDL Application, Summary Technical Documentation
When FDA Comes Calling, Do US Companies Fare Better Than Others?

Last month we explored the rates of FDA inspection conclusions for registered establishments within the US. Several readers posed questions about international inspections, so in this issue we’ll take a look at FDA inspections on a global scale.

Categories: Audit, Regulatory intelligence, News, FDA Tags: OIA, VAI, NAI, Inspections, FDA Inspections, FDA Inspection Data, RIQ, Regulatory Intelligence Quotient
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
Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes

Two US legislators are calling on the US Food and Drug Administration (FDA) to assess the "potential risks" associated with the use of polyethylene microbeads in consumer care products, including toothpastes, saying the products could pose a risk to public health.

Categories: Over the counter drugs, Postmarket surveillance, News, US, CDER Tags: Microbeads, Legislators, Frank Pallone, Kirsten Gillibrand, Polyethylene Microbeads, Toothpaste
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