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.

European Regulatory Roundup: France Wants More Sunshine for Industry Payments (5 March 2015)

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: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
With US' First Biosimilar Approval Expected This Week, is FDA's Biosimilar Labeling Guidance Imminent?

The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US' first biosimilar, Sandoz' Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there's a good chance the biopharmaceutical industry won't have to wait long for the release of that guidance.

Categories: Biologics and biotechnology, Labeling, News, US, CDER Tags: Biosimilar, Biosimilar Labeling Guidance, Guidance, Draft Guidance, INN
Medical Devices Containing BPA Could put some Patients at Risk, EU Committee Finds

A report authored by one of the European Commission's scientific committees has found that the use of bisphenol A (BPA) in medical devices may pose some risk to vulnerable patient populations, including those patients for whom long-term contact with medical devices is necessary.

Categories: Medical Devices, Postmarket surveillance, News, Europe, FDA, EC Tags: bisphenol A, BPA, EFSA
FDA Takes its Fight Against Drug Shortages to the App Store

Drug shortages have been something of an endemic problem in the US for the last several years. For healthcare providers, it can be difficult to tell when a drug is in stock or experiencing a short- or long-term shortage. Now a new mobile application developed by the US Food and Drug Administration (FDA) is hoping to change that.

Categories: Drugs, Distribution, Manufacturing, News, US, FDA Tags: Drug shortages, App store
EMA Releases new Policies Meant to Combat Antimicrobial Resistance

As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products.

Categories: Drugs, Veterinary products, Regulatory strategy, News, Europe, EMA Tags: Antimicrobial resistance, AMR, Veterinary
Regulatory Recon: FDA Grants BMS Lung Cancer Drug Super-Fast Approval (5 March 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
India’s Regulator Talks Improvements

India’s drug regulator has struggled with criticism from inside and outside the country in recent years, but the agency wants the public to know it is taking steps to improve its performance.

Categories: Drugs, Government affairs, News, India, CDSCO Tags: Transparency, H1N1
From Gatekeeper to Facilitator: MHRA Touts Innovation Efforts

Regulatory agencies are often seen by industry as gatekeepers, preventing products from reaching market until after they pass rigorous trials. But in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is trying to position itself as something else, in part: a facilitator.

Categories: Biologics and biotechnology, Clinical, Preclinical, Research and development, Regulatory strategy, News, Europe, EMA, MHRA Tags: Vaccines, Malaria, Viral Vector
Health Canada to Increase GMP Inspections, Promises Greater Transparency

Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future.

Categories: Government affairs, Manufacturing, Postmarket surveillance, News, Canada, FDA, Health Canada Tags: GMP, good manufacturing practice, transparency, inspections
FDA Cracks Down on Facebook Marketing With Four New Letters to Companies

The US Food and Drug Administration (FDA) is increasingly paying attention to social media, and in particular Facebook, as companies use the social networking platform to market their products.

Categories: Nutritional and dietary supplements, News, US, FDA, Advertising and Promotion Tags: Facebook, FDA Regulation of Social Media, FDA Social Media, Warning Letter
Regulatory Recon: SEC Warns Companies About Mischaracterizing FDA Communications (4 March 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 Focus Recap: February 2015

A recap of Regulatory Focus feature articles published in February 2015 for your reading convenience.

Categories: Drugs, Regulatory strategy, Submission and registration, Features, US, Korea, Africa, FDA Tags: outsourcing
Asia Regulatory Roundup: Japan Hits Novartis With Temporary Ban (3 March 2015)

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

Categories: Regulatory intelligence, News, Asia, MHLW Tags: Asia Regulatory Roundup, Regulatory Roundup
Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

Categories: Clinical, Ethics, Government affairs, Reimbursement, Regulatory strategy, Submission and registration, News, Europe, EMA Tags: IQWiG, Health Technology Assessment, AMNOG, Clinical Trial Transparency
Good News for FDA: Both Sides of the Political Aisle Like (and Dislike) it Equally

The US Food and Drug Administration (FDA) is an agency which often courts controversy. But according to a new survey by the polling group Nielsen, the agency must be an equal opportunity offender, because it attracts fairly uniform—and high levels of—support from Democrats and Republicans alike.

Categories: News, US, FDA Tags: Poll, FDA Approval Numbers, FDA Favorability
Regulatory Recon: Canada's Big Shift to Regulatory Transparency (3 March 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
Rare Disease Patient Group Commends EMA, Wants EU-Wide Access to Treatment

A rare disease advocacy network has applauded the European Medicines Agency’s (EMA) efforts to incentivize the development of treatments for rare diseases, but says  the variance in treatment access across the EU is “unacceptable.”

Categories: Government affairs, Regulatory strategy, Submission and registration, News, Europe, EMA, EC Tags: Orphan product designation, rare diseases
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
FDA Finds Prozac in USPlabs Supplement, but Company Claims it’s a Counterfeit

A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products.

Categories: Nutritional and dietary supplements, Postmarket surveillance, News, US, FDA Tags: USPlabs, Warning, Undeclared Ingredient, Prozac
23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.

Categories: Biologics and biotechnology, Drugs, Clinical, Compliance, News, US, CDER Tags: IND, Investigational New Drug Application, Clinical Trial Requirements, 21 CFR 312
Trade Group Wants to See Stricter Limits on Compulsory Licensing

A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015, the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need.

Categories: Drugs, Government affairs, Regulatory strategy, News, US, Europe, Asia, Latin America and Caribbean Tags: Compulsory License, TRIPS, Intellectual Property, PhRMA, US Trade Representative
FDA Seeks New Top Press Official for its Office of Media Affairs

The US Food and Drug Administration (FDA) has started its search for a new leader for its Office of Media Affairs, better known simply as FDA's Press Office.

Categories: News, US, FDA Tags: Office of Media Affairs, FDA Press Office, Assistant Commissioner for Media Affairs
Regulatory Recon: UK Legislators Kill Controversial Medical Innovation Bill (2 March 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 to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year

US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, News, US, CDER Tags: Biosimilar, Biosimilar Labeling, Opioids, Generic Opioids, Abuse-Deterrent Opioids, Guidance, Draft Guidance
Facing Enterovirus Outbreak, HHS Gives FDA Power to Authorize Use of Experimental Diagnostics

The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways.

Categories: In vitro diagnostics, Government affairs, Submission and registration, News, US, FDA Tags: Emergency Use Authorization, EUA, Emergency use Declaration, DHHS, Enterovirus D68
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