Drugs
FDA has issued a draft guidance, Opioid Analgesic Drugs: Considerations for Benefit/Risk Assessment Framework, describing the benefit/risk framework the agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under Section 505 of the Federal Food, Drug, and Cosmetic Act. The document summarizes
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FDA has accepted for priority review a Melinta Therapeutics supplemental NDA for Baxdela (delafloxacin) to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP). The agency has set a user fee review action target date of 10/24. The submission is based on positive results
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FDA has accepted for priority review an Alexion Pharmacuticals’ supplemental BLA for Ultomiris (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, for use in treating people with atypical hemolytic uremic syndrome (HUS) in order to inhibit complement-mediated thrombotic microangiopathy (TMA). Atypical HUS is a severe and chronic
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Sen. Chuck Grassley (R-IA) says he opposes President Donald Trump’s plan to lower prices that Medicare pays for certain drugs by tying them to lower prices paid in other countries, a plan known as the International Pricing Index. “I don’t think this administration’s approach on international
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A month after FDA denied her allegations about deficient FDA inspections at foreign generic drug makers, investigative journalist and Fortune contributor Katherine Eban, went further during a 6/19 Webinar and produced slides showing disparities between agency inspections in India and those at domestic manufacturers. Author of the New York
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AstraZeneca says it supports harmonization of requirements wherever possible and encourages FDA to take the concepts in its draft guidance on bispecific antibody development forward for future updates to harmonized standards as applicable. In a letter commenting on the draft guidance, AZ says that if a comparative clinical study is
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FDA says it will not object to use of certain qualified health claims that consuming eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease. The statement came in an agency response to a 4/
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International Academy of Compounding Pharmacists executive vice president Scott Brunner says FDA “has overreached in implementing provisions” of the Drug Quality and Security Act of 2013, “all but halting common compounding practices that have been safely performed for years and on which patients with legitimate need for compounded medications rely.
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FDA says it is developing scientific tools to facilitate evaluations of peptides and proposed generic equivalents. In an online Regulatory Science Impact Story, the agency discusses the scientific challenge for approval of generic peptide drug products and its research to support development and evaluation of peptide drug products. “Different types
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Pharmaceutical Research and Manufacturers of America (PhRMA) says there are important potential enhancements that can be made to FDA’s current benefit/risk framework, including incorporation of the patient’s voice throughout the drug development lifecycle and utilization of patient experience date to inform regulatory decision-making. Commenting on an
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FDA is asking Congress for statutory improvements to its citizen petitions process. In a 6/19 Senate Committee on Aging hearing on drug prices, CDER director Janet Woodcock said that FDA would like “greater authority to summarily deny petitions submitted with the primary purpose of delaying approval of an application
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RXQ Compounding has recalled all sterile human and animal products within expiry due to a lack of sterility process assurance associated with sterile product manufacturing. A recall notice says that RXQ is voluntarily ceasing all sterile production at its current location while it transitions to the company’s new outsourcing
Drugs
A 10/16-10/26/18 FDA inspection at PRL, Inc., Lobelville, TN, found multiple serious violations of agency regulations for current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. A 6/6 Warning Letter says the violations cause the dietary supplements manufactured at the
Drugs
FDA says it is enhancing the Paragraph 4 patent certification list by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products and information about the dates of first approval, marketing status, and expiration dates of blocking patents. FDA acting commissioner Ned
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FDA has granted Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease. The therapy is designed to deliver a functional copy of the PPT1 gene to the central nervous system and peripheral organs using a combination of intravenous and intrathecal
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The Association for Accessible Medicines (AAM) says it supports the administration’s decision not to include pharmaceuticals and certain pharmaceutical inputs on the most recent list of Chinese exports that would face U.S. tariffs when imported into this country. In a letter to U.S. trade representative Robert Lightizer,
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FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) and its use in treating patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The anti-PD-1 therapy’s approval was based on tumor
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A 5/12-5/30/18 FDA inspection at the Tropical Seas drug manufacturing facility in Holly Hill, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 5/15 Warning Letter also says the firm produces several products that the agency considers
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. PRL, Inc. Lobelville, TN (6/6): FDA inspected the firm 10/2018 and cited multiple serious GMP violations for dietary supplements. The letter also says the agency collected labels
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FDA scientists say they have developed a poliovirus assay that is faster and more versatile than those now used to monitor polio vaccine production, assess patient responses to polio vaccines during clinical trials, and do environmental surveillance of vaccine poliovirus. They say the new assay also is the first to
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Researchers from Harvard Medical School and the University of Calgary say there are similar development times for small molecules and biologic drugs, leading to questions about the longer patent period under the Biologics Price Competition and Innovation Act. “Our study reviewed pre-market times for all new drugs approved by
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A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed journals. “Postmarketing commitments are studies that drug companies agree to conduct at the time of FDA approval, and are not required by statute or regulation,