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.

Three EU Agencies Collaborate on Drug Resistance Study

Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR).

Categories: Drugs, News, Europe, EMA, EC Tags: Antimicrobial Resistance, AMR
Key Changes to South Korean KGMP, IVD Regulations Set for 2015

South Korean medical device regulators will implement significant changes affecting compliance requirements for in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, Korea Tags: Emergo Group, Emergo, South Korea, MFDS
India to Formalize Pre-Submission Meetings

In a move that promises to bring greater clarity to India’s regulatory process for pharmaceutical products, India’s regulator has announced plans to formalize a process for pre-submission meetings (PSMs).

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, News, India, CDSCO Tags: Pre-Submission Meetings, PSM
10 Proposals Worth Paying Attention to in the 21st Century Cures Act

Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act. The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small. But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attract the most attention—and controversy—in the coming months.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Congress, Legislation
Regulatory Recon: FDA a Core Component of Obama Push on Personalized Medicine (30 January 2015)

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 Regulatory Roundup: Should EMA Have Suspended GVK's Drugs? (29 January 2014)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news authored by RAPS staff and members of RAPS' European Advisory Committee.

Categories: Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
MHRA Joins other UK Agencies on Consolidated Website

The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) this week announced major changes to its website meant to incorporate it more thoroughly into the UK government's main website. MHRA announced its plans to move from the old website (www.mrha.gov.uk) to www.gov.uk/mhra in April 2014. The new website launched on 28 January 2015 with a design that incorporates feedback from users on how they use the MHRA website and the Drug Safety Update system.

Categories: Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, MHRA, Communication Tags: GOV.UK, Website, #MHRAonGOVUK, Drug Safety Update
Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements.

Categories: Nutritional and dietary supplements, News, US, FDA Tags: DSHEA, Dietary Supplement, Food Safety Administration, Bill, Senate, Legislation, Dick Durbin, Food
'Right to Try' Legislation Tracker

Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as "Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies.

Categories: Clinical, Ethics, Government affairs, News, US, CDER Tags: Right to Try, Right-to-Try, Compassionate Use, Expanded Access
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: Former FDA Commissioner Testifies Against J&J (29 January 2015)

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 Explainer: The 21st Century Cures Act

On 27 January 2015, the US House of Representatives' Energy and Commerce Committee's Subcommittee on Health released a new bipartisan draft bill that is set to dramatically alter the ways pharmaceutical and medical device products are regulated in the US.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, CBER, CDER, CDRH Tags: Regulatory Explainer, 21st Century Cures Act, 21st Century Cures Initiative, Cures Act, House, Legislation, Congress
US Bests Canada in Approving New Drugs to Treat Cancer, Study Finds

A new study appearing in the medical journal Cancer this week examines the differences in approval times for cancer drugs at the US Food and Drug Administration (FDA) and Health Canada.

Categories: Prescription drugs, Reimbursement, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, Canada, FDA, Health Canada Tags: Cancer, Oncology, Drug Approvals, FDA vs Health Canada
Regulatory Recon: NICE Approves World's Most Expensive Drug for Use (28 January 2015)

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 Adopts International Photosafety Testing Standard

New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients.

Categories: Active pharmaceutical ingredients, Drugs, Clinical, News, US, FDA, ICH Tags: Photosafety, S10, ICH, International Conference on Harmonization, Guidance, Final Guidance, Phototoxicity, Photosensitivity, Photoallergy
Report: FDA Drug, Device Approval Times Improving

A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News, US, FDA Tags: PWC, Report, FDA Approvals, First Cycle Approvals, Review Times
Asia Regulatory Roundup: China's Regulatory Red Tape (27 January 2014)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News, China, India, Oceania, CFDA, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
BREAKING: Congress Seeks Dozens of Major Regulatory Reforms in New Bill

The US House of Representatives' Energy and Commerce (E&C) Committee today released a long-anticipated discussion draft of its 21st Century Cures Act, an ambitious attempt to overhaul the way the US Food and Drug Administration (FDA) regulates new healthcare products in the hopes of incentivizing the creation of new products to treat patients.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Orphan products, Clinical, Submission and registration, News, US, CBER, CDER, CDRH, Advertising and Promotion Tags: 21st Century Cures Act, Congress, FDA Legislation, House, Energy and Commerce Committee
Gilead Seeks Regulatory Shortcut to Bring New HCV Drug to India

Gilead Sciences announced it is extending licensing agreements with eight Indian generic manufacturers to include rights to make a yet-to-be approved drug in combination with Sovaldi (sofosbuvir).

Categories: Prescription drugs, Generic drugs, Clinical, Regulatory strategy, News, India, CDSCO Tags: Gilead, Sovaldi, GS-5816
EMA Touts Big Year for Veterinary Products

The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year.

Categories: Veterinary products, News, Europe, EMA Tags: Veterinary Medicines, MUMS, Minor Use Minor Species, CVMP, vaccines
EMA Looks Back as it Turns 20

If the EU’s medicines regulator were a person, it still wouldn't be old enough to purchase alcohol in the US. Even still, the youthful European Medicines Agency (EMA) says it has much to celebrate this week as it enters its third decade of existence.

Categories: Drugs, News, Europe, EMA Tags: Anniversary
Regulatory Recon: Purple Pill Gets the Green Light : FDA Approves Generic Nexium (27 January 2015)

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
US, India Commit to ‘Collaboration’ in Health Sector

The governments of the US and India released a joint statement affirming the two countries’ commitment to work together in a number of key areas, including intellectual property rights and healthcare-related trade. The statement comes after US President Barack Obama met with Indian Prime Minister Narendra Modi during with India’s his visit coinciding 66th Republic Day celebrations.

Categories: News, US, India, FDA, CDSCO Tags: Intellectual Property, US-India Collaboration
Brazil's ANVISA Granted More Leverage to Prioritize Medical Device-Related Health Risks

A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.

Categories: Medical Devices, Quality, Submission and registration, News, Latin America and Caribbean, Anvisa Tags: Emergo, Brazil
How do you Ensure the Proper Manufacture of a Combination Product? FDA Explains

New guidance issued by the US Food and Drug Administration (FDA) offers an extensive set of recommendations on how members of the pharmaceutical industry can comply with a rule regarding the proper manufacture of combination products.

Categories: Combination products, Manufacturing, Quality, News, US, FDA Tags: Combination Products, CGMP, Quality, Guidance, Draft Guidance
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