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.

Regulatory Recon: FDA’s Cybersecurity Guidance Launches; New Zohydro Filed With FDA (1 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
Regulatory Recon: Sunshine Act Day in America; FDA Releases New Device Quality Data (30 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
Regulatory Recon: FDA Loses Major Case Testing Device Reclassification Authority (29 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
Regulatory Recon: FDA Reopens Comment Period on Social Media Guidance (26 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
Australia’s TGA Launches Web-based ADR Reporting

Australia’s Therapeutic Goods Administration (TGA) has launched a web-based medicines and vaccine related adverse event (adverse drug reaction, or ADR) reporting system for the use of consumers.

Categories: Drugs, News, Oceania, TGA Tags: ADR, Adverse Drug Reaction
Latest Information on Health Canada Review and Approval Times for MDEL Applications

Health Canada regularly publishes performance data with respect to Medical Device License applications (Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL) applications has generally been limited.  To gain a better understanding of MDEL applications, Emergo's Vancouver office contacted Health Canada under Canada’s Access to Information Act asking for additional information.

Categories: Medical Devices, Manufacturing, Submission and registration, News, Canada, Health Canada Tags: Canada, Health Canada, MDEL, Medical Device Establishment License
New COFEPRIS Guidance on Technovigilance Report Submissions

Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance reporting program (link in Spanish) for medical device manufacturers commercialized in the country.

Categories: Medical Devices, Postmarket surveillance, News, Latin America and Caribbean Tags: Mexico, COFEPRIS, Technovigilance
FDA Sends Warning Letter Over Anesthesia Drug's Claims, but Company Defends Ads

New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel.

Categories: Drugs, Compliance, Labeling, News, US, CDER Tags: Warning Letter, Pacira, Exparel, OPDP, Advertising, Promotion
Regulatory Recon: FDA Spying Lawsuit Dismissed (25 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
Custom Medical Device Definition Clarified in Final FDA Guidance

The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations.

Categories: Medical Devices, Submission and registration, News, US, CDRH Tags: Custom Medical Devices, Custom Device Exemption, Custom Device, Guidance, Final Guidance
In First, FDA Sends Warning Letters to Companies Citing Use of Pinterest

The US Food and Drug Administration's (FDA) long history of Warning Letters marked a new milestone today after regulators chided three companies, including one which marketed its product on a medium never before cited by FDA: Pinterest.

Categories: Drugs, Labeling, News, US, CDER Tags: Pinterest, FDA Social Media, Warning Letter
FDA to Spend $16M to Track National Prescribing Trends

The US Food and Drug Administration (FDA) is preparing to put more than $16 million into a multi-year program intended to provide regulators with data on how US patients are prescribed drug products.

Categories: Biologics and biotechnology, Prescription drugs, Postmarket surveillance, News, US, CDER Tags: Prescribing Data, Contract, Source Healthcare Analytics
Regulatory Recon: Calls for Margaret Hamburg's Resignation Shrugged off by FDA (24 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
Regulatory Recon: Industry Calls FDA's Twitter Guidance Unconstitutional (23 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 Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians

The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products.

Categories: Prescription drugs, Generic drugs, Postmarket surveillance, News, US, CDER Tags: REMS, Pilot Projects, REMS Improvements
After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA), the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA subjects new pharmaceutical products to the CSA scheduling process more predictable and less onerous.

Categories: Drugs, Submission and registration, News, US, FDA Tags: DEA, Drug Enforcement Administration, Scheduling, Legislation, Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act, Improving Regulatory Transparency for New Medical Therapies Act
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
FDA Leverages Compassionate Use Program to Allow Access to Experimental Ebola Drug

Canadian biopharmaceutical company Tekmira has announced that the US Food and Drug Administration (FDA) will allow its investigational Ebola drug, TKM-Ebola, to be used by patients under an emergency expanded access program—a stark reversal for the product, which two months ago was subject to a complete clinical hold.

Categories: Biologics and biotechnology, Clinical, Preclinical, News, US, Africa, FDA Tags: TKM-Ebola, Tekmira, Compassionate Use Ebola, Ebola FDA, Expanded Access Ebola
Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved

A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Regulatory strategy, Submission and registration, News, US, CDER Tags: REMS, Fair Access for Safe and Timely (FAST) Generics Act, Legislation, Risk Evaluation and Mitigation Strategies
Regulatory Recon: Another Indian Pharma Company put on FDA Import Alert (22 September 2014)

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Implied Claims of Superiority Lead to Untitled Letter for Pharma Company

The US Food and Drug Administration (FDA) has sent a warning to Cipher Pharmaceuticals over an email marketing piece sent by the company to promote its cholesterol drug Lipofen, saying the piece over-stated the drug's effectiveness.

Categories: Drugs, Labeling, News, US, CDER Tags: OPDP, Untitled Letter, Misbranding, Superiority
A Facebook for Drugs? Regulators Want Help Building Database of What Every Drug Looks Like

A new government project is calling for help from the pharmaceutical industry to make what will be, in effect, a Facebook for drugs.

Categories: Drugs, News, US, CDER Tags: NIH, C3PI, Drug Imaging, What Drugs Look Like, SPLIMAGE
US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends.

Categories: Drugs, Research and development, News, US, CDER Tags: Antibiotics, Antibiotic Resistance, PCAST, Executive Order, Microbial Resistance, Special Medical Use
Regulatory Recon: China Slams GSK With $492M Fine, Deportation for Execs (19 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
Anvisa Launches Drug and Device Monitoring Program

Brazilian regulator Anvisa has launched two programs for monitoring the quality of medicines and health products in Brazil. 

Categories: Drugs, Medical Devices, Postmarket surveillance, Quality, News, Latin America and Caribbean, Anvisa Tags: Brazil
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