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    FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

    In line with efforts to assess the impact and sources of the sartan safety scandal, India-based Torrent Pharmaceuticals and Cadila Healthcare separately drew lengthy US Food and Drug Administration (FDA) Form 483s over, among other issues, failures to thoroughly review unexplained discrepancies. The manufacturing site inspection at Torrent Pharmaceuticals FDA investigators conducted over the course of about a week last month resulted in four inspectional citations, with...
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    Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks, FDA Warns

    The US Food and Drug Administration (FDA) issued a safety communication Friday to warn about adverse event risks in patients’ use of diabetes management devices lacking approvals or clearances. The safety communication raises the agency’s concerns about whether patients are fully aware of the risks of adverse events when using continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems or components that have not undergone FDA review. FDA e...
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    FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May

    Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and Drug Administration (FDA) held a public workshop on Thursday explaining its goals for the initiative and to discuss ongoing issues related to expanded access.   According to Richard Pazdur, director of FDA’s Oncology Center of Excellence, the pilot will be rolled out towards the end of May.   “Access to clinical trials and ac...
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    Health Canada Explains Revised Fees for Drugs and Devices

    Following extensive stakeholder engagement, Health Canada announced Thursday its plan to revise the fees paid by pharmaceutical and medical device companies. The plan will be implemented 1 April 2020. Presently, Health Canada recovers 43% of its costs for regulatory activities from industry, while the remaining costs are covered by Canadian taxpayers. But the revised fees will increase that percentage and better align Canada with other jurisdictions, like Australia and ...
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    WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

    The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of antimicrobials. The 24-page document is intended to raise awareness on interpreting relevant GMP guidance sections applicable to managing waste and wastewater from antimicrobials’ production, considering all GMP implementation aspects and focusing on critically important antimicrobials to establish an...
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    Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

    The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials. Among the FDA officials on its scientific leadership board are Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), CDRH’s lead of cybersecurity initiatives, Suzanne S...
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    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
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    BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices

    CareFusion, a subsidiary of Becton Dickinson (BD), agreed to a $3.3 million settlement to resolve allegations of civil fraud under the False Claims Act over purchases and sales of unapproved devices. The case was brought on by the US Department of Justice (DOJ) and alleged that providers who used CareFusion devices in medical procedures submitted false claims to federal insurance programs, such as Medicare. The devices allegedly lacked US Food and Drug Administration ...
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    FDA Updates on Essure Postmarketing Study

    Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday provided an update on the ongoing postmarketing safety review of the device.   “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” said Center for Devices and Radio...
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    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
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    FDA Unveils 34 New and Revised Product-Specific Draft Guidances

    The US Food and Drug Administration (FDA) on Wednesday released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances. HIV antiretrovirals and antibiotics topped the list of new draft guidances with a total of five, followed by drug products containing active ingredients to treat ophthalmic ailments and cancers. Among the revised product-specific drafts is one for azelaic acid an...
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    European Commission Confirms Quality of South Korean Active Substances

    The European Commission this week confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards. South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US as countries outside of the EU that have been established as manufacturing active substances in an EU-equivalent regulatory system with sufficient rules for good manufacturing practices. “Third countries can ask the Commission to assess whether thei...