Drugs
A clinical trial in South African infants of an improved vaccine for tuberculosis is the subject of an investigational report in The BMJ. The report says the children’s parents committed to the trial based on information that included the statement that the trial vaccine “has been tested in animals
Devices
FDA has issued Becton Dickinson a Warning Letter as part of its investigation of Vacutainer blood collection tubes used in Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems, citing concerns that they may underestimate blood lead levels and give inaccurate results when processing venous blood samples (see earlier
Devices
Edwards LifeSciences has recalled its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. “The overflow material could detach during placement of the delivery system and potentially embolize into the patient,” a recall notice says. The device is used for delivery of the
Devices
David M. Link, the founding director of FDA’s Bureau of Medical Devices (1974-80), precursor organization of CDRH, died 12/23/17 in Massachusetts General Hospital at the age of 87. A Massachusetts Institute of Technology physics graduate, Link’s career at FDA preceded formation of the Bureau, coming
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for RaQualia Pharma’s Entyce (capromorelin), indicated for appetite stimulation in dogs, was 1,645 days. Of this time, 1,589 days occurred during the testing phase, while 56 days occurred during the approval phase. To view the notice,
Drugs
Four healthcare integrity organizations (Transparency International, TranspariMed, Cochrane, and CRIT) are urging governments worldwide to ensure that patients, doctors, and scientists can access the full results of all clinical trials. The four sponsored a study that they say showed that the results of medical research are often reported partially, incorrectly,
Drugs
FDA has released the FDA-483 issued following a 11/27/17-12/22/17 inspection at Pharmedium Services, a Sugar Land, TX, drug outsourcing facility. The form lists these inspection observations: * the quality control unit lacks the responsibility and authority to reject all drug products; * the flow of components,
Drugs
The Congressional Research Service (CRS) says stakeholders have mixed views on FDA guidance and communications in implementing the Drug Quality and Security Act on drug compounding, raising issues that Congress may wish to consider. In a report, “Drug Compounding: FDA Authority and Issues for Congress,” CRS says some in Congress
Drugs
Researchers say that an initial drug safety communication on Sanofi-Aventis’ Ambien (zolpidem) issued by FDA 1/10/13 received significant social media uptake online, while a second communication on 5/14/13 showed almost no social media use. The study, reported in JMIR Public Health and Surveillance, looked at
Drugs
FDA has accepted for priority review an Ionis Pharmaceuticals NDA for inotersen, indicated for treating patients with hereditary transthyretin (TTR) amyloidosis. The agency has set a user fee review target date of 7/6. Inotersen is an antisense drug designed to reduce TTR production. In affected patients, TTR builds up
Drugs
CDER director Janet Woodcock says the Center’s regulatory pathways that expedite the development and approval of new drugs received significant use in 2017. Writing in a report on new drug therapy approvals in 2017, Woodcock reviews usage of the fast track, breakthrough therapy, priority review, and accelerated approval expedited
Drugs
A Pennsylvania state judge has overturned a $27.8 million award approved by a jury for an Indiana couple who said Bayer and Johnson & Johnson failed to sufficiently warn about the risk of internal bleeding with their drug Xarelto (rivaroxaban). Reuters reports the judge ruled after a hearing on
Devices
FDA has approved Medtronic’s new clinician programmer for use with the SynchroMed II Intrathecal Drug Delivery system, an implantable pump that provides targeted drug delivery for chronic pain and severe spasticity. The pump delivers medication directly to the fluid around the spinal cord, which provides relief at lower doses
FDA Policy/General
Federal Register notice: FDA has announced a 3/5-6 Risk Communication Advisory Committee meeting to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The rule was implemented 6/2015 and required changes to
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Vaccines and Related Biological Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/31/2019. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking OMB clearance for an information collection extension for “Extralabel Drug Use in Animals — 21 CFR Part 530 OMB Control Number 0910-0325.” FDA regulations permit it in certain situations to establish a safe level for a residue from the extralabel use of a drug,
FDA Policy/General
Former FDA deputy commissioner for global regulatory operations and policy Howard Sklamberg, now an Akin Gump attorney, says FDA will continue a strong emphasis on enforcement in 2018. In an interview with Corporate Counsel on trends in 2018, he says that FDA commissioner Scott Gottlieb has reorganized the Office of
Devices
FDA has cleared a Masimo 510(k) for home use of the Rad-97 Pulse CO-Oximeter . The device provides continuous monitoring through its Measure-through Motion and Low Perfusion SET pulse oximetry and upgradeable rainbow technologies. It also offers advanced connectivity and communication capabilities for telehealth applications, the company
Devices
FDA has cleared an Attune Medical 510(k) for its EnsoETM, a device capable of administering tube feeds or medication while simultaneously cooling or warming patients using the esophageal space. “The newly-cleared model of EnsoETM, which manages patient temperature through the esophagus, allows for enteral fluid administration with the
Drugs
International Laboratories has recalled one lot of clopidogrel tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as clopidogrel tablets USP 75 mg, but it may contain clopidogrel 75mg or simvastatin tablets USP 10 mg. “Missed doses of
Drugs
A Tufts Center for the Study of Drug Development study with Veeva Systems finds that the volume and diversity of clinical data are presenting integration, compatibility, loading, and interoperability challenges that the drug industry must address to optimize drug development performance. The study (purchase or subscription required), reported in an
Biologics
CBER director Peter Marks says the Center approved several therapeutic “firsts” in FY 2017, representing significant achievements in fulfilling its mission to ensure that safe and effective biological products and related devices are available to the public. In the Center’s annual report, Marks identifies the new therapies as Novartis’