Drugs
FDA is asking drug developers to submit product applications (INDs, NDAs, BLAs, and ANDAs) with SNOMED CT nomenclature to state what disease or diseases the drug is indicated for. SNOMED CT is a nomenclature for the hundreds of thousands of clinical terms that characterize patient care that has been used
Drugs
FDA has approved an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the U.S., Myrbetriq (mirabegron) and VESIcare (solifenacin succinate) are individually
Drugs
Orphan drugs take on average 2.3 years longer to go from patent to launch than other drugs, according to an analysis by the Tufts Center for the Study of Drug Development reported in the May/June issue of its Impact Report (subscription or purchase required). The center studied all
Drugs
FDA has published a question-and-answer document, S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers, with points to consider before incorporating the microsampling method in toxicokinetic studies. The document relates to the S3A guidance implemented by
Drugs
FDA has issued a draft guidance to assist sponsors in the clinical development of drugs to treat uncomplicated urinary tract infections (uUTI). The document specifically addresses the agency’s current thinking on the overall development program and clinical trial designs for drugs to serve as a focus for continued discussions
Drugs
Congress and state legislatures may be where new efforts are made to ease FDA restrictions on off-label promotion of drugs, according to an open-source PLOS Medicine report by Harvard Medical School’s Michael Sinha and Arnold Kesselheim. They cite the 2012 case U.S. v. Caronia in which
Devices
FDA has cleared a Prisyna 510(k) for its Moisyn product designed to treat xerostomia (dry mouth). The condition occurs when there is a decrease in the presence of saliva. The glycomics-targeted therapy that has been shown in a clinical study to reduce pain and increase comfort, the company
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with its development of a policy/guidance document on assessing drug-drug interactions (DDIs) for therapeutic proteins (TPs). The agency split a 2012 DDI draft guidance into two documents published 10/2017: “In Vitro Metabolism- and Transporter-Mediated Drug-
Drugs
CDER director Janet Woodcock says that when a drug candidate qualifies for breakthrough therapy designation, sponsors can get greater input from FDA staff so that development can move along as efficiently as possible. Speaking on a CDER Director’s Corner podcast, Woodcock emphasized that the designation does not signal a
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” The document describes the process that trading partners and stakeholders should use to request such waivers. It also discusses how the
Devices
FDA says there are 10 confirmed cases of infection caused by bacteria within the Burkholder cepacia complex in three states: California (2), New Jersey (1), and Pennsylvania (7). An agency notice says the patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been
Drugs
FDA commissioner Scott Gottlieb says the agency is seeking input from the patient community on how best to strike a balance between restricting loperamide availability to deter its abuse to produce an opioid high and the legitimate need for the drug for patients suffering from chronic diarrhea associated with inflammatory
Devices
FDA has cleared a C4 Imaging 510(k) for its second major brachytherapy product, the HDR MRI Marker. The positive-signal device is intended to be used prior to high-dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for
Devices
Dräger Medical has recalled its Fabius Anesthesia Machines due to a potentially fatal production step error. The inhalation anesthesia machines are used in operating, induction and recovery rooms at hospitals and at magnetic resonance imaging settings with patients of all ages. The Class 1 recall was ordered due to excessive
FDA Policy/General
A House Appropriations subcommittee has voted to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current 2018 spending level. Under the measure, the agency would receive $3.1 billion in discretionary funding, and total funding, which includes user fees, would
Drugs
Pacira Pharmaceuticals is petitioning FDA not to approve any ANDA for a fixed-dose combination of bupivacaine and meloxicam unless the application “includes sufficient evidence from adequate and well-controlled studies, including those that use a factorial design, demonstrating the safety and effectiveness of the combination product. In particular, FDA
Drugs
FDA has issued a draft guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, with agency recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from requirements that drug distribution supply chain trading partners must
Biologics
FDA has approved a Janssen supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The agency’s decision came a few weeks ahead of the scheduled 5/21 user fee
Devices
A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assisted coiling (SAC) of brain aneurysms. The agency says it has received reports associated with the use of these devices in treating unruptured brain aneurysms that “suggest some events
Drugs
Attorney Victor Schwartz (Shook, Hardy & Bacon) says the Supreme Judicial Court of Massachusetts has clouded the question of innovator drug company liability in cases alleging injury caused by a generic drug company’s version of their product. Writing in a Washington Legal Foundation Legal Opinion Letter, Schwartz says the
Drugs
FDA has provided a target date of 8/19 for its response to a Rockwell Medical submission seeking approval of a new contract manufacturer for its approved generic drug Calcitriol vitamin D injection indicated for treating secondary hyperparathyroidism in dialysis patients. The agency indicated that the submission is getting an
Devices
Attorney Bradley Thompson (Epstein, Becker & Green) says he is hearing industry enthusiasm for FDA’s new software precertification program but not enough discussion about the program’s heavy cost to industry. “FDA wants more power. A lot more,” he writes. “And I for one am worried.” Thompson says the