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 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
FDA Legislation Tracker

Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, News, US, FDA Tags: FDA Legislation Tracker, Legislation, Bill, House, Congress, President, FDA Legislation, FDA Bill
When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is.

Categories: Combination products, Drugs, Submission and registration, News, US, CDER Tags: FDC, Fixed-Dose Combination, New Drug, Legislation, House, Congress
FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood.

Categories: Biologics and biotechnology, Blood, News, US, CBER Tags: Guidance Agenda, CBER Guidance Agenda, Ebola, Blood Ban, Donor Deferral Policy, Guidance, Draft Guidance, Final Guidance
FDA Hires World-Renowned Cardiologist to Oversee Medical and Regulatory Policy

One of the world's top cardiologists is set to join the US Food and Drug Administration (FDA) next month to oversee four of its largest regulatory divisions, FDA Commissioner Margaret Hamburg has announced.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA Tags: OMPT, Office of Medical Products and Tobacco, Robert Califf, Deputy Commissioner for Medical Products and Tobacco
'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
Regulatory Recon: FDA Approves Three Drugs, Considers Safety of GM Mosquitos (26 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
EMA Recommends Suspending Drugs over GVK Data Integrity Issues

The European Medicines Agency (EMA) is recommending EU Member States suspend products whose approval relied on clinical trials conducted at GVK Biosciences in Hyderabad, India. The agency cites concerns over “systemic” data manipulation alleged by the French National Agency for Medicines and Health Products Safety (ANSM) following an inspection of GVK’s site in May 2014.

Categories: Active pharmaceutical ingredients, Clinical, Compliance, News, Europe, India, EMA, EC, MHRA, WHO Tags: GVK Biosciences, Data Integrity, Inspections
German Price Watchdog Says ‘No’ to 3 Cancer Drugs

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

Categories: Prescription drugs, Clinical, Reimbursement, News, Europe Tags: IQWiG, Health Technology Assessment, HTA, G-BA, Federal Joint Committee, AMNOG
FDA Touts Major Improvements in Clinical Trial Approval Times for Medical Devices

The US Food and Drug Administration's (FDA) medical device regulator, the Center for Devices and Radiological Health (CDRH), is touting huge improvements to the speed at which it is managing to approve new proposals to start research involving investigational medical devices.

Categories: In vitro diagnostics, Medical Devices, Clinical, Submission and registration, News, US, CDRH Tags: IDE, Investigational Device Exemption
FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards.

Categories: Drugs, Audit, Distribution, Manufacturing, News, US, India, CDER Tags: Ipca Pharmaceutical, GMP, Good Manufacture Practices, Import Alert, Import Alert 66-40
FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

The US Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the US.

Categories: Drugs, Postmarket surveillance, News, US, CDER Tags: PCAC, Pharmaceutical Compounding, Advisory Committee, Pharmaceutical Compounding Advisory Committee
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