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 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
Woodcock: FDA Needs More Funds for Biosimilar Review Program

Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program.

Categories: Biologics and biotechnology, Compliance, Due Diligence, Government affairs, Labeling, Quality, News, US, FDA Tags: biosimilars, BPCIA, biologics, Remsima, Celltrion
FDA Extends Deadline for Some UDI Requirements for Medical Devices

The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices.

Categories: Medical Devices, Labeling, Reimbursement, News, US, FDA Tags: Unique Device Identifier, UDI, National Drug Code, NDC, UDI Rule
House Hearing Focuses on Harm Done by Drug Price Spikes

The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table.

Categories: Drugs, Ethics, Government affairs, Reimbursement, News, US, FDA Tags: Shkreli, Oversight hearing, Turing Pharmaceuticals, Valeant Pharmaceuticals
European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

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

Categories: Biologics and biotechnology, Drugs, Veterinary products, Clinical, Government affairs, News, Europe, EMA, EC, MHRA Tags: database of off-label treatments, UK legislation, pandemic vaccines, CRISPR
Regulatory Recon: FDA Panel Supports New Use for Brintellix, New Studies Confirm Main Results of Califf Led Xarelto Trial (4 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
Woodcock: Drug Safety Surveillance System Ready for Full Operation

The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance, News, US, FDA Tags: Sentinel, Mini-Sentinel, PRISM, BloodSCAN, Active Postmarket Risk Identification and Analysis, ARIA
Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them.

Categories: Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: MRT, mitochondrial DNA, inherited diseases, FDA regulation of MRT, CRISPR
Senators Urge Obama to Take Action on Drug Prices

Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday.

Categories: Drugs, Crisis management, Government affairs, Postmarket surveillance, Reimbursement, News, US Tags: drug prices, Medicare Part D, government drug price negotiations, Obama budget FY2017
Regulatory Recon: Seven Blockbuster Drugs Expected in 2016; Zika Fears Spread (3 February 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Business Skills, Government affairs, Manufacturing, Preclinical, Research and development, Quality, News, US, Canada, Europe, Asia, FDA, EMA, MHRA, WHO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies.

Categories: Clinical, News, US, FDA Tags: Institutional Review Board, IRB, Monmouth Medical Center, Conflict of Interest
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