FDA Policy/General
DEVICES Additive Orthopedics has received FDA 510(k) clearance for its 3D printed titanium digital fusion implant for use in fusion procedures. FDA has approved Advanced Accelerator Applications’ Netspot, the first kit for preparing gallium Ga 68 dotatate injection, a radioactive diagnostic agent for locating somatostatin receptor positive neuroendocrine tumors
FDA Policy/General
Nortech Systems has reached an agreement to acquire Devicix a medical product design and engineering firm. The company says the addition of Devicix will enhance and broaden Nortech’s capabilities for complete design, manufacturing and service, particularly for regulated medical devices. The Second Circuit Court of Appeals has affirmed a
Devices
FDA has approved Zimmer Biomet Spine’s The Tether – Vertebral Body Tethering System, the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. It is
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for the guidance on “Dear Health Care Provider (DHCP) Letters: Improving Communication of Important Safety Information” (OMB Control Number 0910-0754). The document provides recommendations on the content and format of DHCP letters. During 2016-2018, FDA tracked
Drugs
FDA has approved AbbVie’s Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase inhibitor and follow-on therapy to its blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab). Rinvoq is indicated for treating adults with moderately to severely active RA who have had an inadequate response or intolerance to
Devices
FDA has approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged
FDA Policy/General
Federal Register notice: FDA has announced a 9/18 Nonprescription Drugs Advisory Committee meeting on a GlaxoSmithKline Consumer Healthcare NDA for the over-the-counter marketing of nicotine oral spray (1 mg). The proposed OTC use is to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking in adults
FDA Policy/General
Federal Register: FDA has made available a final guidance entitled “Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment.” The document provides recommendations on designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies) for treating osteoporosis. To view the notice,
Drugs
A new study in Clinical Pharmacology & Therapeutics shows that FDA and European Medicines Agency (EMA) reviewers have a “high concordance” (91–98%) in approving/rejecting new drug applications, and that this suggests that “engagement and collaboration on regulatory science has a positive impact.” Conducted by officials from both agencies,
Drugs
FDA has approved a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with narcolepsy. The company says the drug is the first with this indication that is not scheduled as a controlled substance. It says that the selective histamine 3 (H) receptor antagonist/inverse
Devices
FDA and the other members of the Medical Device Innovation Consortium (MDIC) are seeking public comment until 9/13 on the group’s white paper “Best Practices for Communicating Benefit, Risk, and Uncertainty.” An MDIC notice (includes a link to the white paper) says the paper will be part of
Drugs
FDA has granted accelerated approval for Genentech’s Rozlytrek (entrectinib) foe treating adult and adolescent patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. The drug also was approved for treating adults with non-small cell
Drugs
FDA has issued a guidance, Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment, with recommendations for industry use in designing nonclinical bone quality studies to support approval of drugs and biologics intended to treat osteoporosis. The document recommends that sponsors review three agency guidances before starting clinical trials of drugs
Drugs
FDA says that since the demand for immune globulin (IG) products has increased in recent years, despite supply increases, there is an ongoing shortage of IG intravenous and IG subcutaneous products in the U.S. that could affect patient care. An agency statement says that in the setting of increased
Drugs
FDA says Pfizer is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets due to potential microbiological contamination of non-sterile products. An agency statement says the company initiated the recall because the lots may not meet its in-house microbiological specification for the potential presence of Genus pseudomonas
Devices
FDA has granted V-Wave a breakthrough device designation for its interatrial shunt for heart failure (HF). The implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal trial called RELIEVE-HF. The study is enrolling advanced HF patients with preserved or reduced left
Drugs
FDA says it will be making changes to its inactive ingredient database (IID) that provides information on inactive ingredients present in FDA-approved drugs. The information can be used by industry as an aid in developing new drugs, an agency notice says. The notice says FDA will use a phased
Drugs
The New York Times editorial board says that while the goal of getting new medicines to desperate patients as quickly as possible is a worthy one, the uncertainty surrounding expedited drugs has strained the public’s trust and made it easy for insurance companies to deny coverage for such drugs.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910-0131). Such agreements must contain the following: (1) Each firms’ contact information and the identification of the signature authority of the shipper
Drugs
FDA has added three additional questions and answers to the laboratory control section of the questions and answers on current good manufacturing practices guidance. The added questions and answers cover instrument calibration standards for chromatographic systems, system suitability, and trial injections. The agency says that it is essential that analytical
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports an FDA draft guidance on quality considerations for continuous manufacturing and believes the document could benefit from greater clarity on some key concepts. The association’s comment letter also says the guidance’s language could be enhanced to better
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Protection of Human Subjects; Informed Consent; and Institutional Review Boards (IRB) — 21 CFR Parts 50 and 56” (OMB Control Numbers 0910-0755 and 0910-0130). On its own in initiative, the agency is consolidating the information collections