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.

Australia’s TGA Issues Amended Nonclinical Studies Guidance

Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued an amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). 

Categories: Preclinical, News, Oceania, TGA Tags: ARTG, TGA, Australia, Module 4, CTD
RegBits: 4 Things to Know About Healthcare Product Regulation Today (17 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include the European Parliament taking a hard look at drug pricing, recommendations to improve FDA's 510(k) process, a new chocolate-flavored cough syrup which might cause problems, and two new device reclassifications.

Categories: Regulatory intelligence, News Tags: RegBits
FDA Scientific Advisory Committee Meeting Tracker

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
Will Your Generic Drug Application Get Rejected by FDA? New Guidance Documents Explain

The US Food and Drug Administration (FDA) has released two new guidance documents intended to clarify for generic drug makers the criteria by which the agency determines which applications it will "refuse to receive" due to deficiencies in an Abbreviated New Drug Application (ANDA) filing.

Categories: Generic drugs, Submission and registration, News, US, CDER Tags: Refuse-to-Receive, ANDA, Refuse to Receive, Major Deficiency, Minor Deficiency
Regulatory Recon: AZ's New Opioid-Induced Constipation Drug Gets FDA Approval (17 September 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 Formally Authorizes New Diagnostic Meant to Help Fight Against Ebola

The US Food and Drug Administration (FDA) has formally granted clearance to a testing device intended to be used to diagnose patients with the Ebola virus under special, emergency circumstances.

Categories: In vitro diagnostics, Submission and registration, News, US, Africa, CDRH Tags: Ebola, EUA, Emergency Use Authorization, PAHPRA, TaqMan
EU Notified Bodies Update Code of Conduct

The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms.

Categories: In vitro diagnostics, Medical Devices, News, Europe, EC Tags: Emergo Group, CE Mark, European Association for Medical Devices of Notified Bodies
CDER Announces Hire of New Top Regulatory Policy Official

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has announced the hire of a new permanent director of its Office of Regulatory Policy.

Categories: Biologics and biotechnology, Drugs, News, US, CDER Tags: ORP, Office of Regulatory Policy, Grail Sipes
RegBits: 5 Things to Know About Healthcare Product Regulation Today (16 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include a report that FDA's evaluation of antibiotics is lacking, a sea change in the regulation of weight loss drugs, Eli Lilly's push for regulatory harmonization, the UK's breakthrough product designation gets off the ground, and a drug with a side effect of poetry.

Categories: Regulatory intelligence, News Tags: RegBits
Regulatory Recon: Forest, Actavis Sued Over Withdrawal of Alzheimer's Drug (16 September 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 to Test out New Standardized Medical Device Labels in Proposed Study

The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development.

Categories: Medical Devices, Labeling, News, US, CDRH Tags: Medical Device Labeling, Standardized Labeling
RegBits: 5 Things to Know About Healthcare Product Regulation Today (15 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include the US Department of Justice going after Bayer, a shortage of breast implants in Venezuela, a historic drop in the number of generic drug submissions to FDA, new efforts to improve the safety and efficacy of ophthalmic drugs and strange happenings at FDA's docket office.

Categories: Regulatory intelligence, News Tags: RegBits
Regulatory Recon: FDA Holds Nearly 60 Sponsor Meetings on Biosimilars (15 September 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 Regulator TGA Undergoing Reorganization

Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a "smaller and more rational" government.

Categories: Drugs, News, Oceania, TGA Tags: Reorganization, Australian Finance Ministry, Australia
Do Distractions in Drug Ads Put Consumers at Risk? FDA Study to Find out

The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product.

Categories: Biologics and biotechnology, Drugs, Labeling, News, US, CDER Tags: DTC Advertising, Direct-to-Consumer Drug Advertising, Pharmaceutical Advertising, Distractions in Drug Advertisements
RegBits: 5 Things to Know About Healthcare Product Regulation Today (12 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include pressure on FDA to overturn its ban on certain blood donations, the Senate's attempt to overhaul the Time-and-Extent Application process, new problems for Indian drug manufacturers, a look at the advantages of being the first drug to clear FDA's regulatory hurdles, and new classifications for several device classes.

Categories: Regulatory intelligence Tags: RegBits
EU Adaptive Licensing Program Moves Forward, With More Clarity for Sponsors

The European Medicines Agency (EMA) wants to make it easier for companies to use its adaptive licensing pilot program, a new effort to grant accelerated access to medicines intended for limited populations of patients with serious unmet medical needs.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration, News, US, EMA Tags: Adaptive Licensing, Adaptive Licensing Pilot Program
Regulatory Recon: FDA Panel Gives OK to New Novo Nordisk Diet Drug (12 September 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
RegBits: 5 Things to Know About Healthcare Product Regulation Today

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include a Republican attempt to circumvent FDA authority, a group calling for FDA to do more on antibiotics, an examination of FDA's "revolving door" in advisory committee meetings, and new efforts to control opioids.

Categories: News, US, FDA Tags: RegBits
Comparative Claims in Advertising Make Drugs Seem Safer, More Effective

Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month.

Categories: Biologics and biotechnology, Drugs, Labeling, News, US, CDER Tags: OPDP, Study, Advertising, Promotion, Comparative Claims
Regulatory Recon: European Commission Transfers EMA Oversight to Pro-Industry Division (11 September 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
India’s CDSCO Establishes New Clinical Trial Application Requirements

India’s Central Drugs Standard Control Organization (CDSCO) issued an order on 5 September 2014 with “immediate effect” that all applications for the approval of global and new clinical trials must now include additional information.

Categories: Clinical, News, India, CDSCO Tags:
EU Scientists Clear Use of Dental Amalgam, but Call for Further Study

One of the European Commission's (EC) top scientific bodies, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), is calling for public comment on a new report in which it largely downplays concerns about exposure to mercury in dental amalgam while saying that further study is needed.

Categories: Postmarket surveillance, News, Europe, EC Tags: SCENIHR, Dental Amalgam, Dental Mercury
CDER Announces Hire of Top Compliance Official

The US Food and Drug Administration (FDA) has announced the hire of a new senior official, Cynthia Schnedar, who will serve as the director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), its drug compliance enforcement division.

Categories: Drugs, Compliance, News, US, CDER Tags: Office of Compliance, Cynthia Schnedar
Regulatory Recon: NICE Wants Direct Line to Trials Data Seen by Regulators (10 September 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
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