Search Results for Michael Mezher

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WHO Updates Antibiotic Treatment Guidelines for Three STIs By Michael Mezher - Published 30 August 2016

The World Health Organization (WHO) on Tuesday issued new treatment guidelines for three sexually transmitted infections (STIs) (chlamydia, gonorrhea and syphilis), saying the updates respond to an "urgent need" in light of increasing antimicrobial resistance.

Categories: News, WHO, Drugs

Tags: Sexually transmitted infection, STI

Regulatory Recon: FDA Turns Lens to Stem-Cell Therapies; Celltrion's Biosimilar Remsima Picks up More Than 100,000 Prescriptions in Europe (30 August 2016) By Michael Mezher - Published 30 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Finalizes Guidance on Microbiology Data for Antibacterials By Michael Mezher - Published 29 August 2016

The US Food and Drug Administration (FDA) on Friday finalized guidance intended to help drugmakers prepare the data necessary to support the approval of new antibacterial drugs.

Categories: News, US, FDA, Clinical, Drugs, Preclinical, Research and development

Tags: Antibacterial, Antimicrobial resistance, Microbiology data, Final guidance

Regulatory Recon: Theranos to Appeal CMS Sanctions; EMA Reviewing First Herceptin Biosimilar (26 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Warns Pennsylvania Drugmaker Over GMP Violations By Michael Mezher - Published 26 August 2016

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: News, US, FDA, Compliance, Drugs, Manufacturing

FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates By Michael Mezher - Published 25 August 2016

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: News, US, FDA, Labeling, Medical Devices, Postmarket surveillance

Tags: Syringe pumps, Safety communication

Regulatory Recon: FDA Rejects Amgen Drug; Mylan May Have Violated Antitrust Law With Exclusionary School Contracts (25 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: NICE Approves Two New Cancer Drugs for NHS Use; Study Finds Patent System Drives Drug Prices Higher (24 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities By Michael Mezher - Published 24 August 2016

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: News, India, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Unimark Remedies, Data Integrity, Lizard

FDA Clears Test for Measuring Post-Concussion Cognitive Function By Michael Mezher - Published 23 August 2016

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: News, FDA, Medical Devices

Tags: Concussions, ImPACT

Regulatory Recon: FDA Clears Computerized Test for Post-Concussion Cognitive Function; Bioclinica Bought by Private Equity Firm in $1.4B Deal (23 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Pfizer to Buy Cancer Biotech Medivation in $14 Billion Deal (22 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data By Michael Mezher - Published 22 August 2016

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: News, US, FDA, Medical Devices

Tags: Patient-Specific Data, Data Sharing

Regulatory Recon: FDA Expands Use of Edwards Sapien Heart Valves; NICE Rejects Bayer's Nexavar for Liver Cancer Over Cost Concerns (19 August 2016) By Michael Mezher - Published 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA Releases List of Medical Events for Pharmacovigilance Monitoring By Michael Mezher - Published 19 August 2016

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: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events

Regulatory Recon: Medtronic Warns Doctors After 19 Deaths Reported; China to Invest $1B in US Biotech Site (18 August 2016) By Michael Mezher - Published 18 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission By Michael Mezher - Published 18 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT).

Categories: News, US, FDA, Biologics and biotechnology, Blood, Human cell and tissue

Tags: Nucleic acid testing, NAT, Hepatitis B, HBV

Regulatory Recon: FDA Advisers in Favor of Over-the-Counter STI Diagnostics; Report Claims PCSK9 Drugs Could Add $120 Billion to Annual Health Spending (17 August 2016) By Michael Mezher - Published 17 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe By Michael Mezher - Published 17 August 2016

The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November.

Categories: News, US, FDA, Crisis management, Medical Devices, Postmarket surveillance

Tags: Endoscope, Duodenoscopes, Custom Ultrasonics', Superbug Outbreak, CRE, Recall

FDA Warns 14 International Medical Device Companies By Michael Mezher - Published 16 August 2016

The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

Categories: News, China, Europe, Latin America and Caribbean, US, CDRH, Medical Devices

Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter

Regulatory Recon: Vertex Stops Cystic Fibrosis Combination Trial After No Benefit Found; Aurinia Lupus Drug Meets Endpoint Despite 13 Patient Deaths (16 August 2016) By Michael Mezher - Published 16 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Capsule Supplier Changes: FDA Offers an Updated Policy By Michael Mezher - Published 15 August 2016

Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Manufacturing

Tags: Prior Approval Supplement, Gelatin Capsules, Supplier Change

Regulatory Recon: UK Chancellor Pledges EU-Level Science Funding After Brexit; Congress Keeps FDA From Reviewing Human Germline Modifications (15 August 2016) By Michael Mezher - Published 15 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance By Michael Mezher - Published 15 August 2016

The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Postmarket surveillance

Tags: Pharmacovigilance

Regulatory Recon: Novartis Admits South Korean Kickbacks, Denies it Paid Bribes in Turkey; EMA Fires Back at IQWiG Over Adaptive Pathway Criticism (12 August 2016) By Michael Mezher - Published 12 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: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News