Drugs
CDER director Janet Woodcock has proposed changes to her Center’s new drug regulatory program that are intended to free up resources so staff can “focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly,
Drugs
FDA has made available a guidance on “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations on formal meetings between the agency and sponsors or applicants relating to developing and the review of biosimilar or interchangeable biological products. Formal meetings under the guidance
Drugs
Hospira has recalled two lots of naloxone hydrochloride injection, 0.4 mg/mL, 1 mL in 2.5 mL in its Carpuject single-use cartridge syringe system due to the potential presence of embedded and loose particulate matter on the syringe plunger. “In the event that impacted product is administered
Devices
FDA is alerting health care providers about five additional deaths associated with the use of liquid-filled intragastric balloon devices for obesity treatment (see earlier story). “We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients
Devices
FDA has cleared a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing E. coli. The test is performed in a disposable microfluidics-enabled cartridge and is a qualitative, in vitro nucleic acid amplification-based assay that simultaneously detects and differentiates the stx1
FDA Policy/General
Amneal has acquired Gemini Laboratories, a company focused on branded pharmaceuticals, for $117 million. Gemini’s lead product is Unithroid to treat hypothyroidism. Amneal also entered into a licensing agreement for the U.S. market with Spanish company MabXience SL for its biosimilar candidate for Roche’s Avastin (bevacizumab). Surmodics
FDA Policy/General
Guide on How to Develop REMS Shared System Federal Register notice: FDA makes available a draft guidance entitled “Development of a Shared System REMS.” 06/01/2018 ICH Guide on Q12 Post-approval Drug Changes Federal Register notice: FDA makes available a guidance entitled “Q12 Technical and Regulatory Considerations for
Devices
FDA has cleared a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to select from its IB3D range of 3D-printed titanium interbody devices. The clearance allows Medicrea to digitally plan, manufacture in-house and supply a 3D-
Drugs
FDA has approved an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies. Approval is based on data from
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of a Shared System REMS.” The document provides recommendations on developing a risk evaluation and mitigation strategy shared system for multiple prescription drug (including biological) products. It also describes some of the possible benefits of a shared system,
Drugs
Federal Register notice: FDA is making available a draft guidance entitled “Waivers of the Single, Shared System REMS Requirement.” The document describes how FDA intends to consider granting a waiver on the requirement that an ANDA applicant and reference-listed drug maker use a single, shared system for a required
Drugs
Apotex has recalled one lot of fluticasone propionate nasal spray (50 mcg per spray) due to the potential for the product to contain small glass particles. The glass particles could block the actuator and impact pump functionality, a recall notice says. “Local trauma to the nasal mucosa might occur with
FDA Policy/General
FDA has approved an Aratana Therapeutics supplemental New Animal Drug Application for Nocita (bupivacaine liposome injectable suspension) to include its use in cats as a peripheral nerve block to provide regional post-operative analgesia following onychectomy. The Animal Drug User Fee Act review date is set for 7/30. Nocita
Devices
Medtronic has recalled its HeartWare Ventricular Assist Device (HVAD system) because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. An interruption to the electrical connection, which occurs when the power
Drugs
FDA has released a guidance on “Complicated Urinary Tract Infections (cUTIs): Developing Drugs for Treatment.” The document discusses the overall development program and clinical trial designs for drugs to support an indication for treating cUTIs. “We consider the treatment of cUTIs to be an indication distinct from the treatment of
Drugs
FDA has made available a draft guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate criteria for including adolescents in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements.
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions” that describes relevant information that should be included in complete test reports for non-clinical bench performance testing provided in PMAs, HDEs,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessment of Pressor Effects of Drugs” that provides advice to sponsors on the premarketing assessment of a drug’s effect on blood pressure. To view the notice, click here.
Devices
FDA has cleared a Branchpoint Technologies 510(k) for its Aura ICP Monitoring System, an implantable and wireless intracranial pressure (ICP) sensor that allows mobile ICP monitoring in brain-injured patients. The device enables continuous telemetric monitoring of parenchymal ICP including continuous ICP waveforms, the company says. It notes that
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonization.” The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug
Drugs
Allergan has recalled one lot of oral contraceptive Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physician sample pack, indicated for use by women to prevent pregnancy. Allergan recently received a physician report that indicated four placebo capsules (first four on-therapy days) were
Drugs
FDA is publishing two draft guidances intended to reduce innovator drug companies’ ability to use risk evaluation and mitigation strategy (REMS) programs to block time entry of generic drugs. In a statement (contains links to the guidances), FDA commissioner Scott Gottlieb says REMS can be exploited in two ways. At