Drugs
New York attorney general Letitia James has filed what she says is the nation’s most expansive lawsuit against the manufacturers, Sackler family, and distributors of opioids for their role in the nation’s opioid epidemic. The suit, which expands an earlier complaint against Purdue Pharma, alleges that through years
Devices
FDA has cleared a Hitachi Chemical Diagnostics 510(k) for its new high capacity allergy testing instrument, Optigen AP 3600. The device delivers increased throughput and “true walk-away time” compared with its current device, the company says, adding that it can process up to 100 panels, or as many
Drugs
FDA commissioner Scott Gottlieb told a Senate Appropriations Committee subcommittee 3/28 that a new comparative standard is needed for approving new opioid drugs. Gottlieb made the comment during a hearing into the FDA FY 20 budget request that includes a 5.5% increase over FY 19, one of the
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug EDO-S101 (tinostamustine), a potentially first-in-class alkylating deacetylase inhibiting molecule being studied in early phase clinical trials for treating T-cell prolymphocytic leukemia (T-PLL). The extremely rare and aggressive T-cell leukemia is characterized
Drugs
FDA has approved a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Approval is based on data from a 1,651-patient clinical trial that compared Mayzent to placebo in patients
Drugs
FDA has issued a guidance, Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling, to help applicants determine the appropriate placement and content of pediatric information in human prescription drug and biological product labeling. The document says its goal is to provide recommendations to help ensure that information
Devices
DC federal court chief judge Beryl Howell says both FDA and the Judge Rotenbergng Educational Center (JRC) have fallen short in their arguments in a complex Freedom of Information Act (FOIA) case on the agency’s decision to propose a rule to ban use of the Graduated Electronic Decelerator, an
Drugs
The FDA Oncology Center of Excellence (OCE) 2018 annual report describes steps taken to get the Center up and running since its 1/2017 establishment as authorized by the 21st Century Cures Act. Director Richard Pazdur writes that OCE “has collaborated with FDA’s medical products Centers to expedite many
FDA Policy/General
Federal Register notice: FDA has announced a 4/29 regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The purpose of the public meeting is to provide information
FDA Policy/General
Federal Register notice: FDA has announced a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA. Center officials will also hold a panel discussion on pressing FDA initiatives suitable for public-private partnerships. To view the notice, click here.
Drugs
A Washington Post article reports that Gilead Sciences is fighting to prevent the U.S. government from reaping any financial benefit for discovering a use for an HIV drug on which the company makes $3 billion annually. Federal grants from the Centers for Disease Control funded research that proved Gilead’
FDA Policy/General
FDA, along with many other federal agencies, is watching how the Supreme Court handles a case testing the long-standing notion that courts should defer to federal agencies in the agencies’ interpretation of their own regulations. Although the case before the high court involves veterans’ benefits, observers say the decision
Devices
FDA has cleared a MiRus 510(k) for the MoRe-based Europa Pedicle Screw System, which the company says is the first cleared medical device with this new class of implant material. MoRe is characterized as a proprietary molybdenum rhenium superalloy for medical implants. The material “allows for the design
FDA Policy/General
FDA says the iMedDo Web site takes orders for NeuSilver Colloidal Silver and NeuKids lower dose silver for pets and children. A just-released 2/19 Warning Letter gives examples of Web site claims that provide evidence that the products are intended for use as drugs. Since the products are
Drugs
FDA has approved a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. An FDA release says that the product is intended for men having low testosterone levels due to specific medical conditions, and should not be used to treat
Devices
FDA has cleared an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia. The device works by delivering micro pulses of electrical current across a patient’s brain. The company says that clinical studies have demonstrated that the electrical stimulation results in
Devices
For the first time in over 20 years of regulating mammography facilities, FDA is proposing amendments to regulations to help improve the quality of mammography services. An agency news release says the changes would “expand the information mammography facilities must provide to patients and healthcare professionals, allowing for more informed
Drugs
A 3/6-3/15/18 FDA inspection at Thibiant International, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations in its production of finished pharmaceuticals. A 3/6 Warning Letter says the specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Biologics
Janssen Pharmaceutical has submitted a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant. The submission is based on data from the Phase 3 CASSIOPEIA (MMY3006) clinical study, which Janssen
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) of 1988 Waiver Applications.” CLIA requires that clinical laboratories obtain a certificate from HHS before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in CBER’s managed review
Devices
A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein said the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove