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.

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
Major Changes Set for Taiwan’s Medical Device Registration Process

The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.

Categories: Medical Devices, Submission and registration, News, Asia Tags: Emergo, Emergo Group, Taiwan, TFDA, Taiwan Food and Drug Administration
FDA Seeking Safer Medical Devices Through eLabeling Pilot

Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).

Categories: Medical Devices, Labeling, News, US, CDRH Tags: Labeling, Device Labeling, Home Use Devices, Home Use Devices Initiative, Labeling Repository
'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 Calls on Company to Release Data on Controversial Drug (20 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
EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections

A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific advice are more likely to get their products authorized.

Categories: Drugs, Clinical, Preclinical, Regulatory strategy, Submission and registration, News, Europe, EMA Tags: Scientific advice, Small- and medium-sized enterprise, SME
First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports. The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed.

Categories: Biologics and biotechnology, Orphan products, Postmarket surveillance, Submission and registration, News, Europe, EMA, EC Tags: Glybera, Gene therapy, Committee on Advanced Therapies, CAT, Federal Joint Commission, G-BA
Regulatory Recon: Health Insurers Want Reforms to FDA's 510(k) Pathway (17 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 Regulatory Roundup: Blood, Plasma and Human Tissues in Europe (16 April 2015)

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

Categories: Blood, Drugs, Human cell and tissue, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA, NICE Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
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
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
Tougher FDA Approval Process for Opioids Sought by Congress

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA).

Categories: Drugs, Submission and registration, News, US, CDER Tags: Opioids, Zohydro, Bill, Legislators, Senators, Senate, FDA Accountability for Public Safety Act
EMA Releases Draft Guides to Reduce and Report Medication Errors

To address the risk of medication errors, the European Medicines Agency (EMA) has released two new draft documents intended to guide regulators and industry in reporting, evaluating and preventing medication errors.

Categories: Combination products, Drugs, Due Diligence, Labeling, Packaging, Postmarket surveillance, News, Europe, EMA, ICH Tags: Medication errors, Good vigilance practice, pharmacovigilance, GVP
Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book'

Slowly but surely, the US Food and Drug Administration (FDA) is making quiet but substantial updates to its new "Purple Book"— a list meant to describe the degree to which a biosimilar drug is equivalent to the biologic product it references.

Categories: Biologics and biotechnology, News, US, CBER, CDER Tags: Purple Book, Zarxio, Biosimilar, Interchangeable
Regulatory Recon: FDA Approves Amgen's Heart Failure Drug Corlanor (16 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
FDA Seeks Industry Representation on 17 of its Drug Advisory Committees

The US Food and Drug Administration (FDA) is reaching out to the pharmaceutical and biopharmaceutical industries for input on which industry experts should serve on 18 of its influential advisory committees.

Categories: Biologics and biotechnology, Drugs, News, US, CDER Tags: Advisory Committee, AdComm, Industry Representative
FDA Chides Contact Lens Manufacturer for Ignoring Earlier Warning

A recent Warning Letter sent by the US Food and Drug Administration (FDA) to a medical device manufacturer contains good advice to any firm facing an enforcement action from federal regulators: Ignoring the issue will not make it go away.

Categories: Medical Devices, Compliance, Quality, News, CDRH Tags: Warning Letter, Form FDA 483, Form 483
To Boost Transparency, Canada Launches GMP Inspection Database

Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015.

Categories: Compliance, Manufacturing, Postmarket surveillance, News, Canada, Health Canada Tags: Good Manufacturing Practice, GMP, GMP Inspections
Regulatory Recon: WHO Calls for Clinical Trials Transparency (15 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
Asia Regulatory Roundup: Challenge to DRAP CEO Appointment, India's Pricing Chief Ousted (14 April 2015)

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

Categories: Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, Oceania, PMDA, CFDA, CDSCO, TGA, Medsafe Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Generic Viagra Gets a Probable FDA Approval Date (14 April 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
New Report Looks at Challenges to Availability of Blood, Plasma in EU

A new report from Creative Ceutical examines the availability of blood products in the EU and addresses some of the regulatory challenges impacting their supply.

Categories: Blood, Human cell and tissue, Regulatory strategy, News, Europe, EMA, EC Tags: Blood, blood components, blood and plasma derivatives, transfusion
EU Committee Confirms Increased Risk with Ibuprofen at High Doses

A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues.

Categories: Active pharmaceutical ingredients, Prescription drugs, Over the counter drugs, Postmarket surveillance, News, Europe, EMA, EC Tags: Ibuprofen, NSAIDs, PRAC, Pharmacovigilance Risk Assessment Committee
Regulatory Recon: Update to FDA Overhaul Legislation Coming Soon (13 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
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