Drugs
FDA has accepted for review an EMD Serono NDA resubmission for cladribine tablets for treating patients with relapsing forms of multiple sclerosis (MS). The resubmission addresses a 2011 complete response letter requesting an improved understanding of safety risks and the overall benefit-risk profile. The letter said the company’s
Devices
FDA has approved Medtronic’s Implantable System for Remodulin for treating patients with pulmonary arterial hypertension (PAH). The device/drug collaboration leverages Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies to deliver United Therapeutics’ Remodulin (treprostinil) injection. United Therapeutics will lead the product’s promotion with Medtronic’
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Anigan San Ramon, CA (7/25): FDA inspected the firm in April and cited GMP violations associated with its Class 2 Super Jennie and EvaCup reusable menstrual cups. For
Devices
FDA has approved an Integer Holdings PMA for its radial access introducer RadialSeal. The device was designed using the company’s guidewires and hemostatic introducers. The company says it has optimal treatment flexibility provided by a thin walled sheath design that minimizes outer diameter while maximizing inner diameter, and ease
Drugs
The initial and annual biologic product development fee for FY 2019 under the Biosimilar User Fee Amendments of 2017 will be $189,405, according to a fee schedule released by FDA. A Federal Register notice to be published 7/31 also lists the reactivation fee as $370,818, for an
Drugs
FDA says it has found that several additional drug repackagers are recalling valsartan-containing products. In its latest product recall update, the agency says it has recall information from three additional repackagers of valsartan-containing products made by Teva and Prinson, labeled as A-S Medication Solutions, AvKARE, and RemedyRepack.
Devices
FDA says that using energy-based medical devices to perform vaginal rejuvenation, cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. An agency safety communication says the safety and effectiveness of energy-based
Drugs
Reps. Jan Schakowsky (D-IL) and Francis Rooney (R-FL) say they have come together as bipartisan House sponsors of the FAIR (Fair Accountability and Innovative Research) Drug Pricing Act that would require drug companies to give notice and justification for raising the price of a drug. The bill already
Drugs
Ranier’s Rx Laboratory has recalled all sterile compounded drug products within expiry to the hospital or consumer level due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. The concerns were raised during a
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB under the Paperwork Reduction Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription laxative polyethylene glycol 3350. In April, FDA received petitions for a stay on behalf of four ANDA holders: Breckenridge Pharmaceutical and Nexgen Pharma, who submitted a joint petition;
Drugs
FDA has approved Progenics Pharmaceuticals’ Azedra (iobenguane) injection for IV use to treat adults and adolescents age 12 and older with pheochromocytoma or paraganglioma tumors that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy. An agency statement says this is the first FDA-approved
Devices
FDA has cleared a Sekisui Diagnostics 510(k) for the Sekure HbA1c assay and its use as an aid in diagnosing diabetes mellitus. The device is also cleared as an aid in identification of patients at risk for developing of diabetes mellitus, and for monitoring long-term blood glucose control
Biologics
FDA has issued a draft guidance, Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis, with the agency’s assessment of babesiosis as a relevant transfusion-transmitted infection. The document, directed to blood establishments that collect blood and blood components, contains recommendations for donor screening, donation testing, donor deferral, and
Drugs
Rep. Jan Schakowsky (D-IL) has introduced a suite of bills intended to lower prescription drug prices. Included were: * H.R. 6574—the Medicare Fair Drug Pricing Act that she says would lower prescription drug prices for Medicare beneficiaries by allowing the HHS secretary to negotiate the price for the
Drugs
FDA has accepted for review a Nektar Therapeutics NDA for NKTR-181 for treating chronic low back pain in adult patients new to opioid therapy. The new molecular entity is the first analgesic opioid molecule to exhibit a low incidence of specific central nervous system-mediated side effects, such as
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that their approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: CDRH has announced its 2019 Experiential Learning Program, which is intended to provide the Center and other agency staff with an opportunity to understand laboratory practices, quality system management, patient perspective/input, and challenges that impact the medical device development life cycle. This notice invites the device
FDA Policy/General
Draft Guide on Rare Diseases with Substrate Deposition Federal Register notice: FDA makes available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” 07/27/2018 Guide on Certain Pediatric Orphan
Drugs
FDA has issued INSYS Therapeutics a complete response letter for its buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain. The letter adheres to an advisory committee vote in May and “indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate
Devices
FDA has cleared a Cepheid 510(k) for the Xpert Xpress Flu/RSV test, which can be performed in near-patient settings, providing rapid molecular detection of influenza A and B viruses, and respiratory syncytial virus from patient specimens within 20 minutes. In addition to nasopharyngeal swab specimens, the test
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document applies only to diseases with a well-characterized pathophysiology and in which changes