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.

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
Trying to Treat or Cure a Rare Animal Disease? FDA Says it Wants to Help

Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you.

Categories: Orphan products, Veterinary products, News, US, FDA Tags: MUMS, MUMS Act, Funding, Grant OMUMS
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
German Regulator Says EMA's Clinical Trials Transparency Definitions are Too Broad

German health technology assessment body IQWiG has criticized the European Medicines Agency's (EMA) clinical trials data transparency implementation plan, saying its definition of commercially confidential information is overly broad.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, EMA Tags: Germany, RegLink, IQWiG, Clinical Trials Transparency
India Proposes to Waive Phase III Trials for Drugs Approved in a 'Well-Regulated Country'

India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU.

Categories: Biologics and biotechnology, Drugs, Clinical, News, India, CDSCO Tags: DTAB, Drugs Technical Advisory Board
Regulatory Recon: New Batch of Drugs Recommended by EMA (27 February 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
Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices.

Categories: Medical Devices, Postmarket surveillance, News, US, FDA Tags: Diabetes, Safety Warning, Insulin Pen, Injectable Diabetes Medicine
Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts

New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget.

Categories: News, US, FDA Tags: User Fees, PDUFA, MDUFA, BsUFA, AGDUFA, ADUFA, GDUFA, Sequester, Sequestration, Bill, Legislation, Congress
European Regulatory Roundup: UK Ad Authority Chides BI for Beer and Lederhosen (26 February 2015)

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

Categories: Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards.

Categories: Drugs, Regulatory strategy, Submission and registration, News, Europe, EMA, EC, ISO Tags: eCTD, CTD, electronic application forms, eAFs, eSubmissions Roadmap, ISO IDMP
Australian Regulator Says Smoking Device too Similar to Inhaler

The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions.

Categories: Medical Devices, News, Oceania, TGA Tags: Safety Advisory, Metered Dose Inhaler
Regulatory Recon: FDA Willing to Accept Data From a New Type of Cancer Trial (26 February 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
UK Regulator Releases Advertising Report, Complaints Down 32% from 2013

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its annual report on drug advertising. The agency says complaints are down versus previous years, but notes it received more complaints about advertisements made on websites and social media.

Categories: Prescription drugs, Over the counter drugs, Government affairs, News, Europe, MHRA, Advertising and Promotion Tags: Advertising and Promotion, Social Media
Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), fresh off the appointment of a permanent director last month, is hoping to hire someone to act as the office's second-in-command.

Categories: Generic drugs, News, US, CDER Tags: OGD, Office of Generic Drugs, OGD Deputy Director
FDA Provides New Guidance on Whole Slide Imaging Devices

New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices.

Categories: Medical Devices, Compliance, News, US, CDRH Tags: Guidance, Draft Guidance, Digital Pathology Whole Slide Imaging Device, WSI, Class I
Compliance is Hard: FDA Warns Company After Finding Cialis Ingredient in its Product

For one dietary supplement company warned by the US Food and Drug Administration (FDA) this week, regulatory compliance has something in common with what the company claims its "male enhancement" product will do to users: It's hard.

Categories: Nutritional and dietary supplements, Compliance, News, US Tags: Warning Letter, Compliance
Too Fast, or Too Slow? Public Disagrees Over Pace of FDA's New Drug Approvals

According to a new survey, the US Food and Drug Administration (FDA) is in a lose-lose situation when it comes to regulating healthcare products.

Categories: Biologics and biotechnology, Drugs, Research and development, News, US, FDA Tags: Poll, Survey, Drug Approvals too Fast, Drug Approvals too Slow
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