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.

CDRH Develops 'Regulatory Toolkit' to Promote Device Innovation

Officials from the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) say their efforts to develop a "regulatory toolkit" for sponsors has helped promote medical device innovation in the US, according to a recent viewpoint in JAMA Ophthalmology.

Categories: Medical Devices, Clinical, Preclinical, Regulatory strategy, News, US, CDRH, Communication Tags: Investigational device exemption, IDE, Early feasibility study, EFS
EMA’s Open Trial Data Policy After Five Years: Long Waits, Lengthy Correspondence

The European Medicines Agency’s (EMA) five-year-old policy of allowing some academic researchers and journalists to access what’s considered commercially confidential information in the US has resulted in a lengthy process that can take considerable back and forth correspondence with the agency, according to a new study.

Categories: Drugs, Clinical, Government affairs, Preclinical, Research and development, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: EMA open trial data, clinical trial data access, freedom of trial information
New FDA Draft Guidance for Orthopedic Device Developers

The US Food and Drug Administration (FDA) on Thursday released new draft guidance to help Class II and III orthopedic device developers understand what type of information to include in their submissions for devices using ultrahigh molecular weight polyethylene (UHMWPE) material.

Categories: Medical Devices, Clinical, Due Diligence, Packaging, Project management, Research and development, News, US, FDA Tags: FDA draft guidance, orthopedic device guidance, UHMWPE
EMA Offers New Draft Guidance on Developing Treatments for Chronic Heart Failure

The European Medicines Agency (EMA) on Thursday released new draft guidance for public consultation on the clinical development of new drugs to treat chronic heart failure (CHF).

Categories: Drugs, Clinical, Due Diligence, Government affairs, Preclinical, Research and development, News, Europe, EMA Tags: chronic heart failure, heart failure treatments, heart failure hospitalization, EMA guidance
Regulatory Recon: New Precedent on NDA Approval Dates; Walgreens May Pull Theranos Deal (11 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

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

Categories: Biologics and biotechnology, Drugs, Veterinary products, Ethics, Government affairs, Reimbursement, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, MHRA, NICE Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI
CDC, NIH 'Working Closely' With FDA on Zika Response

At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus.

Categories: Biologics and biotechnology, Government affairs, Submission and registration, News, US, Latin America and Caribbean, FDA, Communication Tags: Zika virus, Accelerated approval, CDC, NIH, Anthony Fauci, Tom Frieden
US FDA Inspections in China: An Analysis of Form 483s from 2015

As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Audit, Crisis management, Compliance, Government affairs, Manufacturing, Quality, News, US, China, India, FDA, CFDA, CDSCO Tags: Form 483s, FDA in China, CFDA, API inspections
Regulatory Recon: FDA Advisory Panel Backs Celltrion's Remicade Biosimilar in 21-3 Vote (10 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Generic Drug Review Dashboard: FDA Offers a First Look

As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs).

Categories: Generic drugs, Due Diligence, Government affairs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: generic drug review, ANDA backlog, FDA and ANDAs, generic drug applications
FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US.

Categories: Active pharmaceutical ingredients, Drugs, Audit, Crisis management, Manufacturing, News, US, India, FDA Tags: Ipca Laboratories, data integrity violations, GMP warning letters
EU Regulation Requires New Safety Features on Drug Packaging by 2019

A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019.

Categories: Prescription drugs, Labeling, Packaging, News, Europe, EMA, EC Tags: Falsified Medicines Directive, Unique Identifier, Anti-tampering device
Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request.

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Clinical, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Zika, Cancer Moonshot, FDA 2017 budget, Obama budget, device regulations
Senate Committee Advances Seven Bills Linked to Drug, Device Regulations and Research

The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Government affairs, Manufacturing, Postmarket surveillance, Quality, News, US, FDA Tags: Senate HELP committee, drug legislation, device legislation, NIH legislation, FDA bills
Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Business Skills, Government affairs, Manufacturing, Research and development, Quality, News, Asia, PMDA, CFDA, CDSCO, TGA Tags: Indian drug imports, CFDA, TGA, drug tariffs, cancer guidance
Regulatory Recon: Sen. Franken Introduces Bill to Add Zika to Priority Review Voucher Program, UN Calls for WHO Reform (9 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Releases Draft Guidance on Displays Devices for Diagnostic Radiology

The US Food and Drug Administration (FDA) released a new draft guidance intended to clarify the information device makers should include in their 510(k) submissions for displays used in diagnostic radiology.

Categories: Medical Devices, Submission and registration, News, US, CDRH Tags: Mammography, Display device, Radiology, 510(k)
US, EU & WHO Launch Efforts to Accelerate Zika R&D

One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease.

Categories: In vitro diagnostics, Research and development, Regulatory strategy, Submission and registration, News, US, Europe, Latin America and Caribbean, FDA, EMA, EC, WHO Tags: Zika virus, Emergency Use Assessment and Listing, EUAL, Priority Review Voucher, PRV
Regulatory Recon: Theranos Gets More Time to Respond to CMS Inspection, Patient in Halted Akashi DMD Trial Dies (8 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Recon: FDA Rejects Expanded Label for CF Drug Kalydeco, EMA Says Faulty Device in Trial Doesn't Impact Xarelto Safety (5 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies

A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, US, FDA Tags: Electronic health records, EHR, Sentinel, Mini-Sentinel, Medical Countermeasures, MCM
Phase I Death in France: An Update on ANSM’s Investigations

New information from France’s National Agency for Medicines and Health Products Agency (ANSM) was released this week on the Phase I clinical trial halted last month after the death of one healthy volunteer and the hospitalizations of five others.

Categories: Drugs, Clinical, Crisis management, Research and development, Quality, News, Europe, EMA Tags: ANSM, Bial, Biotrial, France clinical trial
Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Audit, Compliance, Manufacturing, Quality, News, Canada, Health Canada Tags: Health Canada, Gilead, Sanofi, Actavis, Baxter, GMP inspections
FDA Briefing Documents Offer Support for Remicade Biosimilar

The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing.

Categories: Biologics and biotechnology, Clinical, Due Diligence, Government affairs, Research and development, News, US, FDA, EMA Tags: Remicade, biosimilar, 351(k) application, clinical trials to support biosimilars
After Political Pressure, Califf Vows to Re-Examine FDA’s Opioid Policies

President Barack Obama’s nominee to be the next commissioner of the US Food and Drug Administration, Dr. Robert Califf, on Thursday unveiled new policies aimed at “reversing” the opioid epidemic in the US.

Categories: Drugs, Crisis management, Government affairs, Research and development, News, US, FDA Tags: opioids, FDA, Senator Markey
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