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.

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Combination products, Manufacturing, Quality, News, US, FDA Tags: Combination Products, CGMP, Quality, Guidance, Draft Guidance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
Senator Wants Companies Who Break FDA Regulations to Help Fund NIH

US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH).

Categories: Biologics and biotechnology, Drugs, Compliance, Ethics, News, US, FDA, Advertising and Promotion Tags: Elizabeth Warren, NIH, National Institutes of Health, Regulatory Noncompliance, Swear Jar, Congress, Senate, Legislation, Medical Innovation Act
FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014

Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator.

Categories: Biologics and biotechnology, Drugs, Clinical, Ethics, News, US, CDER Tags: Compassionate Use, Expanded Access, IND, Investigational New Drug Application
Regulatory Recon: J&J Says China's Drug Approval Process Getting Harder (23 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
China Adopts Milestone Device Good Supply Practices

China’s Food and Drug Administration (CFDA) has issued the country’s first Good Supply Practices (GSP) regulations that apply to all Class 1, 2 and 3 medical device distributors, as well as third-party logistics service providers for medical devices.

Categories: Medical Devices, Distribution, News, China, CFDA Tags: RegLink, RegLink News, Good Supply Practices, GSP, Distribution
India Proposes New Requirements for Bioequivalence Studies

India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export.

Categories: Drugs, Clinical, News, India, CDSCO Tags: RegLink News, RegLink, Bioequivalence
European Regulatory Roundup: UK PM Calls for Lighter Biopharma Regulation (22 January 2014)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Regulatory intelligence, News, Europe, EMA, EC, MHRA, NICE Tags: Regulatory Roundup, EU Regulatory Roundup, European Regulatory Roundup
Which of FDA's Drug Advisory Committees Were Most Active in 2014?

Each year, the US Food and Drug Administration's (FDA) various advisory committees offer the agency dozens of recommendations on whether to approve new drugs, whether new policies are needed to better regulate drugs and whether an existing product should remain on the market.

Categories: Biologics and biotechnology, Drugs, Regulatory intelligence, News, US, FDA Tags: Advisory Committee, FDA Advisory Committees, FDA Advisory Committee Votes, Tarius
What's a ‘High Priority’ Drug? Generic Drug Industry Offers Ideas to FDA

The generic pharmaceutical sector is calling on the US Food and Drug Administration (FDA) to make changes to a proposed policy that would make it easier for regulators to prioritize the review of some new generic drug products for which there is no previously approved generic.

Categories: Generic drugs, Submission and registration, News, US, CDER Tags: First-to-File, 180-Day Exclusivity, ANDA, Abbreviated New Drug Application
EMA Seeks Feedback on Clinical Trial Database

In 2014, the European Medicines Agency (EMA) made headlines when it announced it would require pharmaceutical companies to report the results of their clinical trials. Now, in a new notice, EMA is asking for help in determining how it should make that information available to the public, including how it should balance transparency with confidentiality. 

Categories: Biologics and biotechnology, Drugs, Clinical, News, Europe, EMA Tags: Clinical Trials Transparency
Regulatory Recon: FDA's Blood Donation Policy Incoherent for Transgender Persons (22 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
Australian Regulator Hits Restart on Plan to Name Biosimilars

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy.

Categories: Biologics and biotechnology, Labeling, News, Oceania, TGA, WHO Tags: Biosimilars, INN, WHO, Naming, World Health Organization, Australian Biological Name, ABN, International Nonproprietary Names
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