Drugs
FDA has issued a final rule establishing that 24 active ingredients in over-the-counter antiseptic products for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital are not generally recognized as safe and effective. The agency says it issued the final rule after
Drugs
FDA says it has updated the labeling for Novartis’ cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. An agency news release says Tasigna was approved in 2007 and is indicated for treating patients with Philadelphia chromosome positive (Ph+) chronic myeloid
Drugs
In a draft guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases, FDA says it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases unless use of the drug in the pediatric subpopulation meets the regulatory for
Devices
CDRH and CBER are proposing a Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form. A Federal Register notice says the proposed program reflects goals for streamlining malfunction reporting outlined in the MDUFA 4 commitment letter. The goals include permitting
Drugs
FDA has published a draft guidance, Information Requests and Discipline Review Letters under GDUFA, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during review of an ANDA as contemplated in GDUFA 2. The document says the guidance does not
Drugs
FDA has approved La Jolla Pharmaceuticals’ Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. An FDA news release says that in a clinical trial of 321 patients with shock and a critically low blood pressure, significantly more patients responded
Drugs
A 7/10-7/14/17 FDA inspection at Deserving Health International, Richmond, British Columbia, Canada, a manufacturer of sterile homeopathic eye drops, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. Specific violations cited in a 12/18/17 Warning Letter were: * failing to follow appropriate
Drugs
FDA says its review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. A drug safety communication says that in 2011
Devices
Physio-Control has recalled its defibrillation electrodes due to incorrect placement instructions for infants that were depicted on artwork. The Class 1 recall affects defibrillation electrodes used on the Lifepak Express AED, Lifepak CR Plus AED, Lifepak 1000 defibrillator, or Lifepak 500 Biphasic AED with a pink connector. Defibrillation electrodes
Devices
Sterilmed has begun a Class 1 recall of its Reprocessed Agilis Steerable Introducer Sheath due to an improper seal of the sheath hub. “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that
Biologics
FDA has accepted for review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The agency granted a priority review, and set a user fee review target date of 5/1. The submission is based
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has sent Vanthi (Newtown, PA) a Warning Letter objecting to a medical conference marketing panel for its Lomaira (phentermine hydrochloride USP) tablets. “This panel makes false or misleading claims and/or representations about the risks associated with Lomaira and omits material facts,
Drugs
FDA is requiring a new class Warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for MRIs. The Warning concerns retention of gadolinium in patients’ bodies, including the brain, for months to years after receiving the drugs. “Gadolinium retention has not been directly linked to adverse health
Drugs
A 3/6-3/9/17 FDA inspection at Prosana Distribuciones SA de CV, Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/18/17 Warning Letter says that specific violations were: * failing to have for each batch of drug product
Drugs
A 4/6-4/14/17 FDA inspection at Fresenius Kabi Oncology Limited, Hirnachal Pradesh, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. The specific violation cited in the letter was failing to thoroughly investigate any
Drugs
FDA has issued a draft guidance, Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders, with recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or
Drugs
FDA has issued the latest CDER Data Standards Program Board action plan with a quarterly update for internal and external stakeholders on progress on current CDER data standards initiatives. The document says program initiatives are derived from the major areas of regulatory business activities — drug development and premarket review, drug
Drugs
CDER director Janet Woodcock says that the Center’s experience monitoring pharmacy compounding since passage of the Drug Quality and Security Act “has demonstrated a need for further improvement in compounding practices.” Writing in the New England Journal of Medicine, Woodcock says that the agency has discovered problematic conditions in
Drugs
Bloomberg News columnist Max Nisen says FDA commissioner Scott Gottlieb may not always be the friend the drug industry expected to see in the commissioner’s office. Nisen’s column says that Gottlieb is the only Trump administration official to follow through on the president’s rhetoric about high drug
Drugs
FDA has issued a draft guidance on “Information Requests and Discipline Review Letters Under GDUFA” that outlines how such letters will be used during the ANDA review process. The recently reauthorized generic drug user fee program calls for using the letters to provide “preliminary thoughts on possible deficiencies as each
Drugs
FDA is revising a listing that identifies brand drugs that do not have any generic competition. Key changes to the listing include presenting the information more clearly by drug product instead of by active ingredient to help firms identify products for potential development, an agency posting says. The list now
Drugs
FDA has released a draft guidance on “Investigational IVD Used in Clinical Investigations of Therapeutic Products” to help researchers involved in precision medicine development determine if an in vitro diagnostic (IVD) device used in a drug study will require a separate agency review from the drug being studied. The agency