Drugs
FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 13 to six to not recommend approved for a Lipocine NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). This is the second
Drugs
FDA is asking the DC federal court to dismiss United Therapeutics Corp.’s (UTC) suit seeking seven years of market exclusivity for its Orenitram (oral treprostinil), indicated for treating pulmonary arterial hypertension. FDA rejected the company’s application and UTC appealed that decision to the court. In its filing in
Drugs
FDA is requiring labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children under age 18. An agency news release says the “serious risks of these medicines outweigh their potential benefits in this population.” After the safety labeling changes are made,
FDA Policy/General
Federal Register notice: FDA has announced a 2/14-15 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled to review a Pacira Pharmaceuticals supplemental NDA for Exparel (bupivacaine liposomal injectable suspension), indicated to produce local analgesia and as a nerve block to produce regional analgesia. To
FDA Policy/General
Federal Register notice: FDA has requested OMB clearance for an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) OMB Control Number 0910-0616.” The certification is intended to affirm that all applicable requirements for submitted information to the national clinical
Drugs
Endo says a Florida U.S. attorney has subpoenaed documents and information relating to products containing oxymorphone. “The subpoena broadly requests documents including, among others, those produced in past or pending lawsuits and those relating to product safety and efficacy, overdoses, diversion, thefts, overprescribing, dependency or tolerance, withdrawal addictiveness, adverse
FDA Policy/General
FDA has released its 2018 Strategic Policy Roadmap that identifies four priority areas to be the focus of additional policy activity in 2018—reducing the burden of addiction crises that are threatening American families; leveraging innovation and competition to improve healthcare, broaden access, and advance public health goals; empowering consumers
Devices
FDA is giving healthcare providers information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems. A MedWatch notice says most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of the events were associated with cardiopulmonary arrest
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