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.

New to FDA's Advisory Committee Briefing Documents: Patient Testimony

Patients and their advocates appear to be getting more prominent attention from the US Food and Drug Administration (FDA) if a recent release of documents in advance of an upcoming advisory committee meeting is any indication.

Categories: Regulatory strategy, News, US, FDA Tags: Patient Testimony, Advisory Committee
What's a 'New' Drug in the EU? EMA Explains

When is a chemical entity considered a new active substance (NAS)? The European Medicines Agency (EMA) answers that question and provides clarification on the type of information required to demonstrate that a substance qualifies for NAS status in a draft reflection paper published Friday.

Categories: Drugs, Regulatory strategy, Submission and registration, News, Europe, EMA Tags: New Active Substance, NAS
Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.

Categories: Medical Devices, News, US, CDRH Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill
Regulatory Recon: FDA Skeptical of New Amgen Drug (27 April 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
Gilead to Offer Free HCV Treatment in Georgia

Gilead Sciences has launched an initiative to provide its hepatitis C (HCV) treatment Sovaldi to patients in the Republic of Georgia free of charge.

Categories: Drugs, Government affairs, News, Europe, WHO Tags: Gilead, Sovaldi, Republic of Georgia, Harvoni, Hepatitis C, HCV
Regulatory Recon: EMA Recommends 11 New Medicines (24 April 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
WHO Makes Drug Side Effects Easier to Find With New Database

Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, WHO Tags: Adverse drug reactions, individual case safety reports, ADR, ICSR, pharmacovigilance, VigiAccess, VigiBase
European Regulatory Roundup: ENVI Wants Limits on Proposed Regulatory Cooperation (23 April 2015)

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

Categories: Regulatory intelligence, News, Europe, EMA, EC Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
HHS Says it Will Shield Maker of Ebola Therapy ZMapp from Legal Liability

The US Department of Health and Human Services (DHHS) says it will shield the manufacturer of the investigational Ebola virus treatment ZMapp from legal liability under a federal law intended to incentivize the development of new medical products for medical emergencies.

Categories: Biologics and biotechnology, News, US, FDA Tags: Ebola, ZMapp, HHS, PAHPRA, PREP Act, Liability
'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: Gilead's Big Bid to Wipe out HepC in Georgia (23 April 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 Court Says French Decree Violated Transparency Rules

The European Court of Justice (ECJ) has issued a judgment clarifying EU transparency rules for products covered by national health insurance as they apply to ongoing legal battles in France.

Categories: Drugs, Government affairs, Reimbursement, News, Europe Tags: European Court of Justice, ECJ, Alfalastin, Javlor
FDA Willing to Accept Different Endpoints When Assessing Lung Cancer Drugs

Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week.

Categories: Drugs, Clinical, News, US, CDER Tags: NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Final Guidance, Guidance, Endpoints
Indian Parliament Proposes Extending Price Caps to all Drugs

Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs.

Categories: Drugs, Government affairs, Labeling, News, India Tags: National Pharmaceutical Pricing Authority, NPPA, Drug Price Control Order
FDA Making Changes to its Drug Advertising Review Process

A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators.

Categories: News, US, CDER, Advertising and Promotion Tags: Form FDA 2253, OPDP, Promotion, Advertising, Promotional Materials, Guidance, Draft Guidance
Legislation Overhauling Approval of Drugs, Devices Coming Next Week

Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act, a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products.

Categories: News, US, FDA Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Legislation, Bill, Congress
FDA Says Chinese API Manufacturer Falsified Drug Data

The US Food and Drug Administration (FDA) has sent a Warning Letter to a Chinese active pharmaceutical ingredient (API) manufacturer after finding that the firm did not exercise proper control over its manufacturing data.

Categories: Active pharmaceutical ingredients, Compliance, Manufacturing, News, US, China, CDER Tags: Warning Letter, Data Integrity
Regulatory Recon: How a Killer Pharmacy Led to Compounding Changes at FDA (22 April 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
Poor-Quality Medicines a 'Global Pandemic,' New Research Says

Poor-quality and falsified medicines are "potentially devastating" to global health, researchers and regulators said on Monday in a collection of articles posted in the American Journal of Tropical Medicine and Hygiene.

Categories: Active pharmaceutical ingredients, Drugs, Distribution, Postmarket surveillance, Quality, News, Europe, Asia, Latin America and Caribbean, Africa Tags: Falsified medicine, counterfeit, substandard drugs
Asia Regulatory Roundup: India Targeting Drug Data Fraud (21 April 2015)

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

Categories: Regulatory intelligence, News, Asia Tags: Regulatory Roundup, Asia Regulatory Roundup
FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards.

Categories: Medical Devices, Clinical, Ethics, News, US, CDRH Tags: GCP, Good Clinical Practice, Guidance, Draft Guidance, FDASIA Section 1123, Clinical Data
FDA Kicks off Generic Drug User Fee Reauthorization Process

Regulators and generic pharmaceutical companies, start your engines. The race to the next reauthorization of the Generic Drug User Fee Act (GDUFA) has begun.

Categories: Generic drugs, Regulatory strategy, Submission and registration, News, US, CDER Tags: GDUFA, Generic Drug User Fee Act, Office of Generic Drugs
Regulatory Recon: FDA's New Commissioner Plans to 'Hold Course' (21 April 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
Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products.

Categories: Drugs, Distribution, Labeling, Packaging, News, India, CDSCO Tags: Good distribution practice, GDP, temperature storage instructions
FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies.

Categories: In vitro diagnostics, Medical Devices, News, US, CDRH Tags: LDTs, Lab Developed Tests, CMS, CLIA, FDA/CMS Task Force on LDT Quality Requirements
« 1 2 3 4 5  ... »