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.

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News, US, CDER Tags: Biosimilar, Biosimilar Labeling, Opioids, Generic Opioids, Abuse-Deterrent Opioids, Guidance, Draft Guidance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
Regulatory Recon: California Bill Would Force Drug Companies to Publish Regulatory Costs (25 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
Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients

Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective.

Categories: Over the counter drugs, Submission and registration, News, US, CDER Tags: Sunscreen, Sunscreen Innovation Act, SIA, TEA, Time and Extent Application
With Eye on Improving Quality, Indian Regulator gets First ISO Certification

India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO).

Categories: Government affairs, News, India, CDSCO, ISO Tags: ISO, International Organization for Standardization, ISO 9001:2008, ISO 9001, Quality Management Systems, QMS
FDA Again Targets Cosmetic Company L’Oréal for Improper Marketing

In the latest escalation between US regulators and cosmetic companies, the US Food and Drug Administration (FDA) has issued a warning to cosmetic giant L’Oréal —the company's second letter in three years—accusing it of improperly marketing several of its skin care products.

Categories: Drugs, Labeling, News, US, FDA, Advertising and Promotion Tags: Cosmetics, L'Oreal, Warning Letter
ICH Takes Step Toward New eCTD Version

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD).

Categories: Submission and registration, News, US, Europe, Japan, FDA, EMA, PMDA, ICH Tags: ICH, International Conference on Harmonization, eCTD, electronic submissions
Asia Regulatory Roundup: China Rolls out New Clinical Practice Rules (24 February 2015)

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

Categories: Regulatory intelligence, News, Asia Tags: Asia Regulatory Roundup, Regulatory Roundup
FDA Plans to Fund Research on Generic Drug Efficacy, Medical Countermeasures and More

The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA).

Categories: Biologics and biotechnology, Drugs, News, US, FDA Tags: BAA, Broad Agency Announcement, Regulatory Science
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