Devices
FDA has issued a safety alert about online marketers selling pre-owned test strips or test strips not authorized for sale in the U.S. to consumers. The agency says the test strips may not be safe to use because they might not have been stored properly or their expiration
FDA Policy/General
Federal Register notice: FDA has announced a 5/14 Oncologic Drugs Advisory Committee meeting. In the morning session, the committee is scheduled to discuss a Daiichi Sankyo NDA for pexidartinib capsules, indicated for treating adult patients with symptomatic tenosynovial giant cell tumor. In the afternoon session, they will discuss Daiichi’
FDA Policy/General
Federal Register notice: FDA has announced a 5/7 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. Panel members are scheduled to discuss approaches to evaluate the effect of renal impairment on drug exposure, and best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. To view the
FDA Policy/General
Federal Register notice: FDA has determined that Casper Pharma’s Antivert (meclizine hydrochloride) chewable tablets were not withdrawn from sale for reasons of safety or effectiveness. Antivert is indicated for treating vertigo associated with diseases affecting the vestibular system. The determination allows FDA to continue to approve ANDAs that refer
Devices
FDA has cleared a Spry Health 510(k) to market the Loop System, a clinical-grade wearable that measures pulse oximetry, respiration rate and heart rate. The device is intended to allow clinicians to remotely monitor their patients with chronic diseases, such as chronic obstructive pulmonary disease, according to the
Drugs
Bellerophon Therapeutics and FDA have reached agreement on the regulatory approval pathway for INOpulse, a proprietary pulsatile nitric oxide delivery system for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Based on recent data and INOpulse’s safety profile, Bellerophon says FDA agreed that it can measure
Drugs
FDA has approved a ViiV Healthcare NDA for Dovato (dolutegravir and lamivudine), as a complete regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. The
FDA Policy/General
Final Guide on REMS Factors Federal Register notice: FDA makes available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” 04/05/2019 Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA Federal Register
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” The document is intended to clarify how FDA applies factors in determining whether a risk evaluation and
FDA Policy/General
Federal Register notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Cortisporin is
FDA Policy/General
Federal Register notice: FDA has determined that Teva’s Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference the products if all other legal and regulatory
Biologics
Celgene has submitted a BLA for luspatercept, an erythroid maturation agent for treating adult patients with very low to intermediate risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions. It is also seeking approval for treating adult patients with beta-thalassemia-associated anemia
Drugs
Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals have agreed to pay a total of $122.6 million to resolve allegations that they each violated the False Claims Act by illegally paying Medicare or Civilian Health and Medical Program co-pays for their own products through foundations that the companies used as
Drugs
FDA has posted a 24-page Form 483 from a 5/2018 inspection of Akorn’s Decatur, IL sterile drug manufacturing operation. The inspection documented “poor aseptic processing techniques” and the company’s inadequate system for monitoring environmental conditions in aseptic processing areas. Additionally, the inspection form cited Akorn for
FDA Policy/General
The Alliance for a Stronger FDA has submitted Congressional testimony that asks appropriators to increase President Trump’s FY 2020 budget proposal by 15% ($60 million) for an overall increase of $418 million. The $60 million boost should go towards food safety activities, the Alliance says, such as “enhanced funding
Devices
FDA has cleared an Avanos Medical 510(k) for its improved On-Q with Bolus pump for reducing postoperative opioid use to achieve pain management. The device is intended to provide “customized control for patients recovering from post-surgical pain by delivering continuous, non-opioid medication to the surgical site
Drugs
FDA has issued a guidance, REMS: FDA’s Application of Statutory Factors in Determining When a REMS is Necessary, to clarify how the agency applies the factors from the Federal Food, Drug, and Cosmetic Act to determine whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that
FDA Policy/General
Federal Register notice: FDA is proposing a new information collection on “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The collection is intended to support recommendations found in the same-titled agency guidance, which outlines the requirements and recommendations for
Drugs
FDA has released a list of 40 angiontensin II receptor blockers (ARBs) for which the agency has reached the conclusion that they do not contain any known nitrosamine impurities. In a statement linking to the list and other documents, FDA commissioner Scott Gottlieb and CDER director Janet Woodcock say they
Drugs
FDA has approved a Pfizer supplemental NDA for Ibrance (palbociclib) capsules and their use in combination with specific endocrine therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in male patients. The drug was initially approved in 2015 for treating certain women
Drugs
FDA has accepted for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonist for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The agency 2/2018 rejected the submission, citing concern about
Drugs
FDA has extended by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The extension is necessary for FDA to review a agency-requested data submission, according