Drugs
A Democratic-introduced bill this week contains several provisions affecting FDA that, even though the bill is expected to stall, are likely to be under consideration in the next coronavirus package with which the House and Senate come to terms, according to the Alliance for a Stronger FDA. The Trump
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Three months ahead of schedule, FDA 5/15 approved a Deciphera Pharmaceuticals NDA for Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor. The drug is indicated for adult patients who have received prior treatment with three or more
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FDA has issued Blueprint Medicines a complete response letter for its NDA for avapritinib, indicated for treating adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). The company did not disclose FDA’s reasons for the letter or whether is requested any additional data or clinical trials. Avapritinib
Drugs
The Eastern Oklahoma federal court has entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three company officials that requires them to immediately stop distributing colloidal silver products. The company offered the products for sale to treat coronavirus and other diseases. In granting the order,
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FDA has denied a 1/22 Crowell & Moring petition asking that it not finalize with states a drug compounding memorandum of understanding (MOU) or take any regulatory action against drug compounders based on a regulatory definition of “distribution” that includes “dispensing” until conditions specified in the petition are met.
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FDA says it has updated its guidance for pharmacy compounders who experience shortages due to the Covid-19 public health emergency of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. An agency notice says the update clarifies that
Drugs
Zealand Pharma has filed an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia. The submission is based on data from pivotal and confirmatory Phase 3 trials, where primary and all key secondary endpoints were successfully achieved with a median time to blood glucose recovery of
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CBER has released the transcript from the 3/3 public workshop on facilitating end-to-end development of individualized therapeutics. At the workshop, CBER senior scientist Gopa Raychaudhuri said the session would focus on individualized therapeutic products regulated by CBER, specifically gene therapies and phage therapies. “We work in close
Drugs
FDA has issued a refusal to file letter to Bristol Myers Squibb and Bluebird Bio for a BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March. In the letter, FDA told the company that the BLA’s
Drugs
MasterPharm has recalled one lot of finasteride plus 1.25mg capsules because they were found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested at an independent laboratory, according to a recall notice. Ingesting the
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A new report from the National Academies of Sciences, Engineering, and Medicine says there is a lack of scientific evidence to support the safety or effectiveness of compounded topical pain creams. The report, “Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use,” recommends changes such as
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FDA has released for public viewing a standard memorandum of understanding (MOU) between the agency and states as part of the regulatory process addressing compounded drug distribution while preserving access. An agency notice says the compounding program is an FDA priority that develops policies that ensure appropriate access to lawfully-
Drugs
Vanda Pharmaceuticals says it has reached agreement with FDA to resubmit an NDA and supplemental NDA for Hetlioz (tasimelteon) for treating Smith-Magenis Syndrome (SMS). In March, Vanda received a refusal to file letter, asking that the company separate its NDA into two submissions — a supplemental NDA for the solid
Drugs
FDA has added content to the question-and-answer appendix in its guidance on conducting medical product clinical trials during the Covid-19 public health emergency. An online notice says the guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video
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CDER has outlined recommendations for drug sponsors seeking product development inquiries for Covid-19 products. For example, the Center’s Office of New Drugs (OND) recommends that development for Covid-19 related drugs be supported by randomized controlled trials. OND also urges sponsors to seek initial advice under a pre-
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FDA has released the FDA-483 issued to Nephron Pharmaceuticals Corp., doing business as Nephron Sterile Compounding Center, West Columbia, SC, with nine inspection observations. The document lists these observations: * failing to write and follow test procedures relative to appropriate lab testing for sterility; * failing to follow procedures designed to
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The Court of Appeals for the DC Circuit has rejected Pharmaceutical Manufacturing Research Services’ (PMRS) request for a review of FDA decisions rejecting the company’s NDA for a prescription opioid drug and denying the company a hearing. The court concluded that the FDA decision to deny the PMRS application
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it “applauds FDA for seeking input on the capacity planning adjustment (CPA) methodology and the recommendations being made” in an agency report on assessing the resource needs of PDUFA and BsUFA. Completion of the assessment of CPA methodology meets an agency commitment
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An FDA 8/9-8/21/19 inspection at Images Unlimited Products, doing business as Cellect Products & Oglethorpe, as well as an agency review of labels for the firm’s products and a Web site, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations.
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fusion Health and Vitality, Alpharetta, GA (5/11): FDA reviewed the company’s Web sites and determined that it sold unapproved products intended to mitigate, prevent, treat, diagnose, or
Drugs
FDA says Web sites operated by Fusion Health and Vitality, Alpharetta, GA, sold products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 5/11 Warning Letter says the firm’s products were unapproved new drugs that were also misbranded. The letter says that as of
Drugs
FDA has updated its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by CDER, including biological products approved in NDAs that were deemed to be licenses on 3/23 (transition biological products). The update also includes additional downloadable report features, and historical