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 Pennsylvania Drugmaker Over GMP Violations

The US Food and Drug Administration (FDA) has warned Frontida BioPharma Inc. for numerous good manufacturing practice (GMP) violations and failing to provide FDA officials with requested information during the course of an inspection.

Categories: Drugs, Compliance, Manufacturing, News, US, FDA Tags:
Regulatory Recon: Theranos to Appeal CMS Sanctions; EMA Reviewing First Herceptin Biosimilar (26 August 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
Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain.

Categories: Drugs, Government affairs, Postmarket surveillance, Product withdrawl and retirement, News, US, FDA Tags: opioid, off-label marketing, pharmaceutical lawsuits, Insys Therapeutics
Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Research and development, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, Canada, Europe, FDA Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures
Senators to FDA: Where are the Alternatives to Mylan’s EpiPen?

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

Categories: Combination products, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: EpiPen, Mylan, Robert Califf, Grassley, Klobuchar, Ron Johnson
FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates

The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients.

Categories: Medical Devices, Labeling, Postmarket surveillance, News, US, FDA Tags: Syringe pumps, Safety communication
European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Crisis management, Compliance, News, Europe, EMA, EC, MHRA Tags: medical app, pharmacovigilance, Boehringer, AbbVie
Regulatory Recon: FDA Rejects Amgen Drug; Mylan May Have Violated Antitrust Law With Exclusionary School Contracts (25 August 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
PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO are pleased with the performance goals outlined by and for the agency from 2018 to 2022.

Categories: Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA, Business and Leadership Tags: PhRMA, BIO, PDUFA VI, Prescription Drug User Fee Act
FDA Warns Indian API Maker Unimark for Deviations at Two Facilities

The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India.

Categories: Active pharmaceutical ingredients, Manufacturing, News, India, FDA, APIs Tags: Unimark Remedies, Data Integrity, Lizard
Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA

The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval for a new strength of a drug.

Categories: Active pharmaceutical ingredients, Generic drugs, Quality, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: refuse-to-receive an ANDA, ANDA submission, generic drug submission
Regulatory Recon: NICE Approves Two New Cancer Drugs for NHS Use; Study Finds Patent System Drives Drug Prices Higher (24 August 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 Finalizes Two Medical Device Guidelines

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform benefit-risk determinations.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Preclinical, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: FDA guidance, medical device guidance, benefit-risk determinations of devices
FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

Categories: Drugs, Medical Devices, Clinical, Due Diligence, Preclinical, News, US, FDA Tags: GLP regulations, nonclinical studies, quality inspections, FDA proposed rules
Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: Medical Devices, Government affairs, Postmarket surveillance, Preclinical, Project management, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs
Regulatory Recon: FDA Clears Computerized Test for Post-Concussion Cognitive Function; Bioclinica Bought by Private Equity Firm in $1.4B Deal (23 August 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
Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016)

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

Categories: Drugs, Due Diligence, Preclinical, News, Asia, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms
FDA Clears Test for Measuring Post-Concussion Cognitive Function

The US Food and Drug Administration (FDA) on Monday announced it cleared the first computer-based tests for measuring cognitive function after a suspected concussion in both adults and children.

Categories: Medical Devices, News, FDA Tags: Concussions, ImPACT
Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: Drugs, Medical Devices, Crisis management, Government affairs, Quality, News, US, FDA, FTC, Business and Leadership Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders
Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data

Several groups representing the medical device industry and patients are calling for more clarity from the US Food and Drug Administration (FDA) on its recent draft guidance on sharing patient-specific device data with patients.

Categories: Medical Devices, News, US, FDA Tags: Patient-Specific Data, Data Sharing
PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: Biologics and biotechnology, Combination products, Drugs, Clinical, Government affairs, Manufacturing, Quality, News, US, FDA Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act
Regulatory Recon: Pfizer to Buy Cancer Biotech Medivation in $14 Billion Deal (22 August 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
EMA Releases List of Medical Events for Pharmacovigilance Monitoring

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, Europe, EMA Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events
Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance

Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets.

Categories: Drugs, Clinical, Compliance, Manufacturing, Quality, News, US, FDA Tags: chewable tablets, chewable drugs, pharmaceutical comments on FDA guidance, FDA draft guidance
Regulatory Recon: FDA Expands Use of Edwards Sapien Heart Valves; NICE Rejects Bayer's Nexavar for Liver Cancer Over Cost Concerns (19 August 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
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