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.

EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility.

Categories: Generic drugs, Clinical, Ethics, Preclinical, Submission and registration, News, Europe, India, FDA, EMA, WHO Tags: Data integrity, Notice of Concern, Semler
Regulatory Recon: Zika Impact Worse Than Expected; Questions on Cancer Moonshot Coordination (29 April 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 Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator.

Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Compliance, Ethics, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, FDA, Health Canada Tags: Indian drug manufacturing, Indian API manufacturing, Polydrug Laboratories, product quality complaints, FDA warning letters
Public Citizen Sues FDA Over Redacted Advisory Committee Info

The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members.

Categories: Government affairs, News, US, FDA Tags: Public Citizen, Advisory Committee Members, Freedom of Information,
Device Supplier Settles Monopoly Allegations With FTC

UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market.

Categories: Medical Devices, Crisis management, Due Diligence, Distribution, Manufacturing, Regulatory strategy, News, US, Europe, FTC, Business and Leadership Tags: PEEK, medical device suppliers, polymer suppliers, Invibio, Evonik, Solvay
CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines.

Categories: Biologics and biotechnology, Crisis management, Ethics, Government affairs, Postmarket surveillance, News, US, CBER Tags: vaccine adverse events, vaccine reporting, electronic reporting of adverse events
Regulatory Recon: Abbott, AbbVie Announce Billion Dollar Acquisitions; New Bill Would Overhaul Opioid Approval Process (27 April 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: EMA to Allow Patient-Reported Outcomes in Oncology Trials (28 April 2016)

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

Categories: Biologics and biotechnology, Drugs, Clinical, Regulatory intelligence, Submission and registration, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, MHRA, EMA, oncology trials
Arbitrary Pharmaceutical Price Gouging: Valeant Defends its Business Model

As the anger over Martin Shkreli’s infamously steep and entirely arbitrary price hike of a rare disease drug has subsided, Congress has begun to turn its attention to other companies, such as Valeant Pharmaceuticals, which rely on price gouging as the foundation of their business models.

Categories: Drugs, Business Skills, Crisis management, Reimbursement, News, US Tags: Shkreli, Valeant, Ackman, Pershing, Walgreens
GDUFA Reauthorization: GPhA and Catalent Make Specific Requests

As the US Food and Drug Administration (FDA), industry and other stakeholders continue to meet and discuss what provisions the next iteration of the Generic Drug User Fee Act (GDUFA) should contain in 2017, both the Generic Pharmaceutical Association (GPhA) and contract manufacturer Catalent, among others, have outlined particular requests.

Categories: Generic drugs, Compliance, Due Diligence, Government affairs, News, US, FDA Tags: GPhA, Catalent, GDUFA II, GDUFA negotiations
Regulatory Recon: FDA Rejects Digital Pill Combo; Novartis Periodic Fever Drug Wins Three Breakthrough Designations (27 April 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
Democrats Renew Call for $1.9 Billion to Fight Zika

House and Senate Democrats are calling on their Republican counterparts to support a new standalone bill, supported by President Barack Obama, calling for $1.9 billion to fund efforts to combat the Zika virus.

Categories: Government affairs, News, US, Latin America and Caribbean, FDA Tags: Zika
Cash-Strapped MHRA Looks to Stay Flexible

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Government affairs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA, NICE, IMDRF, WHO Tags: MHRA funding, Brexit, CAMD, ICMRA, IMDRF
Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries

Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program.

Categories: Biologics and biotechnology, Drugs, Distribution, Ethics, Government affairs, Preclinical, Regulatory strategy, Regulatory intelligence, Submission and registration, News, Europe, Asia, Africa, Middle East, Oceania, EMA, EC, WHO Tags: Article 58, LMIC medicines, vaccines, tuberculosis, drug approvals, NRAs
Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said.

Categories: Biologics and biotechnology, Drugs, Clinical, Research and development, News, US, FDA Tags: C-Path, biomarker validation, data sharing
Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016)

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

Categories: Drugs, Government affairs, Medical writing, Product withdrawl and retirement, Quality, News, Asia, CFDA Tags: Harvoni, Sovaldi, CFDA inspections, Merck Serono, Sandoz
Regulatory Recon: FDA Approves New Renal Cell Carcinoma Drug; Reduced ANVISA Fees for Some Due to Lawsuit (26 April 2016)

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

Categories: Biologics and biotechnology, Drugs, Clinical, Crisis management, Government affairs, Labeling, Manufacturing, News, US, Canada, Europe, Asia, Middle East, FDA, EMA, EC, MHRA, Health Canada, CDSCO, Anvisa, IMDRF Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Updated: FDA Investigates Study Showing Yeast Infection Drug Increases Risk of Miscarriage

The US Food and Drug Administration (FDA) said Tuesday that it’s evaluating the results of a Danish study that found a possible increased risk of miscarriage with the use of Diflucan (fluconazole), a Pfizer treatment for yeast and other fungal infections.

Categories: Drugs, Crisis management, Postmarket surveillance, News, US, FDA Tags: Pfizer, yeast infection, miscarriage, Diflucan, fluconazole
Health Canada Finalizes IVD Labeling Guidance After 18 Years

The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998.

Categories: In vitro diagnostics, Labeling, News, Canada, Health Canada Tags: Electronic Labeling, E-labeling, Blood glucose monitoring systems
Regulatory Recon: New FDA Guidance on Assay Development and Validation; Battle Over Drug Pricing Hits Germany (25 April 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Government affairs, Manufacturing, Quality, News, US, Canada, Europe, Asia, Middle East, FDA, EMA, EC, MHRA, Health Canada, PMDA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Panel Votes Against Approval for Sarepta DMD Drug

Following a contentious debate pitting young boys with the terminal illness Duchene Muscular Dystrophy (DMD) against the US Food and Drug Administration (FDA), an advisory panel of outside experts on Monday voted against the approval of Sarepta Therapeutics’ controversial investigational drug eteplirsen to treat DMD.

Categories: Drugs, Research and development, News, US, FDA Tags: Sarepta, eteplirsen, DMD, BioMarin
FDA Seeks Ban on Electric Stimulation Devices Used in Aversive Therapy

The US Food and Drug Administration (FDA) says it intends to ban electrical stimulation devices (ESDs) used to treat aggressive and self-injurious behaviors after an advisory panel recommended banning the devices in 2014.

Categories: Medical Devices, News, US, FDA Tags: Electrical stimulation devices, ESDs, Aversive therapy, Banned devices, Judge Rotenberg Educational Center, Torture
Regulatory Recon: Walgreens Struggles to Distance Itself From Theranos, AstraZeneca to Sequence 2  Million Genomes (22 April 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
Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics

The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos.

Categories: Generic drugs, Government affairs, News, Japan, China, Korea, India, Asean Tags: MSF, Doctors Without Borders, KEI, HIV, TB, Indian generic drugs
EMA Clarifies How to Include API Mix Data in a Marketing Application

The European Medicines Agency's (EMA) has released a new questions and answers document intended to guide sponsors on which procedures to follow when submitting a marketing authorization application for a drug containing an API mix.

Categories: Active pharmaceutical ingredients, Drugs, Manufacturing, Submission and registration, News, Europe, EMA Tags: API mix, Excipients
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