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.

Asia Regulatory Roundup: India's Push for Regulatory Consolidation (25 November 2014)

Welcome to our Asia Regulatory Roundup, a new weekly overview of the top regulatory news in Asia, the Middle East and Oceania.

Categories: Regulatory intelligence, News, India, Middle East, CDSCO Tags: Asia Regulatory Roundup, Regulatory Roundup
FDA Cracks Down on Companies Using Search Engine Promotion Tactics

The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) are cracking down on three alleged marketers of unproven Ebola treatments by using an unusual tactic: Cracking down on their use of search engine marketing tactics.

Categories: Drugs, News, US, FDA, FTC, Advertising and Promotion Tags: Metadata, Meta Data, Metatags, Meta Tags, FTC, Warning Letter
FDA Recommends New Testing Standards for Home Use Devices

A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.

Categories: Medical Devices, Manufacturing, News, US, CDRH Tags: Home Use Device, Home Use Initiative, Guidance, Final Guidance
How Should FDA Regulate Lab-Developed Tests? Agency Wants to Know

The US Food and Drug Administration (FDA) plans to hold a meeting to collect public feedback on a controversial proposal to revoke a longstanding regulatory exemption for lab-developed tests (LDTs) and regulate them more like traditional medical devices.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: LDT, Lab Developed Test, CLIA, FDA Workshop
Regulatory Recon: Limits Sought on FDA Authority to Regulate Clinical Support Software (25 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
FDA, CDC Preparing Updated Form to Record Vaccination Problems

The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form.

Categories: Biologics and biotechnology, Postmarket surveillance, News, US, CBER Tags: VAERS, VAERS 1.0, VAERS 2.0, Vaccine Adverse Event Reporting System, CDC, Centers for Disease Control and Prevention, Vaccine
Bill Would Benefit Developers of Drugs for Rare Diseases

A new bill introduced in the US House of Representatives would grant existing pharmaceutical products an additional six months of marketing exclusivity if a company is able to demonstrate the product is able to treat or prevent a rare disease or condition.

Categories: Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, News, US, CBER, CDER Tags: OPEN ACT, Bill, Legislation, Congress, Orphan Drug, Exclusivity
FDA Puts Major Restrictions on Power Morcellators Following Cancer Concerns

US regulators today announced major restrictions on laparoscopic power morcellator (LPM) devices following major concerns that the devices could be harming patients.

Categories: Medical Devices, Postmarket surveillance, News, US, CDRH Tags: Power Morcellator, Laparoscopic Power Morcellator, Guidance, Guidance in Immediate Effect, IIE Guidance
FDA Planning Six New Drug, Device Regulations for 2015

The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development.

Categories: Regulatory intelligence, News, US, FDA Tags: Unified Agenda, Planned FDA Regulations, Proposed FDA Regulations
Regulatory Recon: FDA to Place Additional Inspectors in China (24 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
This Week in Medical Device Regulation (17-21 November 2014)

Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.

Categories: Medical Devices, Regulatory intelligence, News Tags: This Week in Medical Device Regulation, Medical Device Regulation, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
This Week in Pharmaceutical Regulation (17-21 November 2014)

Welcome to This Week in Pharmaceutical Regulation, your weekly review of regulatory news and intelligence.

Categories: Biologics and biotechnology, Drugs, Regulatory intelligence, News Tags: This Week in Pharmaceutical Regulation, Pharmaceutical Regulation, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
RegBits: The Biggest Regulatory Stories of the Week (That we Forgot to Cover)

As much as we manage to cover here at Regulatory Focus, there's often just as much that we don't manage to write about despite our best intentions. RegBits is our occasional look at some of the biggest and most interesting stories that managed to escape our keyboards, but not our attention.

Categories: News, FDA Tags: RegBits
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: FDA Approves Abuse-Resistant Competitor to Zohydro (21 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
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
« 1 2 3 4 5  ... »