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A new FDA drug quality annual report says that FDA in 2019 performed 1,258 drug quality surveillance inspections, with 42% of these conducted in the U.S. Inspections in the European Union were next on the list with 17% conducted there, followed by India (15%), China (9%) and the
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CDER Office of Antimicrobial Products (OAP) deputy director John Farley has been appointed permanent director. He had been serving as acting director since 8/2019 when former director Edward Cox left the agency to join Regeneron as regulatory affairs vice president. Cox had served as OAP director since 2006, after
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FDA has issued a guidance entitled “Temporary Policy on Prescription Drug Marketing Act (PDMA) Requirements for Distribution of Drug Samples During the Covid-19 Public Health Emergency.” Under the policy, which is effective during the Covid emergency, FDA says it will not take action against a manufacturer or authorized distributor
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FDA has added a new section to a clinical trial guidance on 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. The added content is contained in a question-and-answer appendix in the guidance titled “Conduct of Clinical Trials of Medical
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FDA has announced a 6/30 virtual meeting entitled “Regulated Bioanalysis Workshop: Requirements and Expectations.” This training is focused on presenting an overview of how CDER approaches different issues in bioanalysis. Attendees are expected to gain an understanding of how bioanalysis must be performed to adequately support regulated activities and
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FDA has accepted for review an Adamas Pharmaceuticals supplemental NDA for Gocovri (amantadine) as a treatment for “off” episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy. Currently, Gocovri (amantadine) is approved to treat dyskinesia in such patients, with or without other dopaminergic medications. In the submission,
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FDA has granted Fitbit an emergency use authorization for its emergency ventilator, Fitbit Flow, for use during the Covid-19 public health emergency. The device is modeled after “standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and
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FDA is reminding laboratory staff to use transport media that are compatible with Covid-19 testing platforms and the processes used in their laboratory to process samples collected. “There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate or similar chemicals
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Harvard Medical School researchers say that manufacturers of investigational antimicrobial products frequently qualified for expedited testing and review programs offered by FDA. Writing in The Lancet Infection, the researchers say that since 2012 FDA has promulgated antimicrobial-specific guidance documents that reiterate the agency’s ongoing commitment to regulatory flexibility
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India-based Aurobindo Pharma says that an FDA inspection earlier this year at its oral solid manufacturing facility in Dayton, NH, AuroLife Pharma, resulted in a Form 483 citing nine GMP observations. The agency notified the company that the 1/13 to 2/12 inspection was classified as “official action
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FDA has issued a compliance guide for inspections of CDER-led or CDRH-led combination products. The document says that a single establishment inspection report and, where applicable, FDA-483 should be used to document all observations made during an inspection at a combination product manufacturer. The guide’s contents
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FDA has accepted for review a PharmaEssentia BLA for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for treating rare blood cancer polycythemia vera in the absence of symptomatic splenomegaly. Polycythemia vera begins in a disease-initiating stem cell in the bone marrow that results in a chronic red
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FDA has approved a Merck NDA for Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. The drug was previously approved to treat patients with complicated urinary tract infections and
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FDA has issued an immediately-in-effect guidance, Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the Covid-19 Public Health Emergency, to apply to IRB review of only individual patient expanded access INDs. The document does not apply to
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FDA has extended by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. The revised user fee review action date is now expected in September. Ofatumumab is a fully human anti-CD20 monoclonal
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FDA says it is making its Covid My Studies app (formerly known as FDA My Studies) available to investigators as a free platform to obtain informed consent from patients for eligible clinical trials when face-to-face contact is not possible or practical due to Covid-19 control measures. An
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FDA has issued an immediately-in-effect guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency, to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial
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The Motley Fool, a financial and investing advice company, says the FDA Drug Competition Action Plan initiative that the agency started in 2017 to make prescription drugs more affordable has worked well for consumers, but at the expense of lower revenue and profits for many companies. In an online post,
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University of Washington professor of medicine and epidemiology Bruce Psaty says an FDA draft 2020 guidance on evaluating the safety of new drugs for improving glycemic control “represents a serious step backward.” Writing in a comment letter, Psaty says an earlier 2008 guidance “revolutionized the quantity and quality of information
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The Association of American Physicians and Surgeons has filed suit against FDA in western Michigan federal court to force the agency to stop limiting access to hydroxychloroquine, a drug touted by president Trump, for prophylactic use against Covid-19. The conservative nonprofit group’s complaint alleges that the agency is
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Quantitative methods and modeling (QMM) covers a broad spectrum of tools that can be used in modernizing generic drug development, says FDA in an online Regulatory Science Impact Story. The post says that in both new and generic drug development, mathematical models can be thought of as knowledge management systems
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CytoDyn has filed a BLA for Pro 140 (leronlimab (PRO 140) for use in combination therapy for treating HIV infection. Leronlimab is described as an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases. The company says