Devices
Dräger Medical has recalled its Fabius Anesthesia Machines due to a potentially fatal production step error. The inhalation anesthesia machines are used in operating, induction and recovery rooms at hospitals and at magnetic resonance imaging settings with patients of all ages. The Class 1 recall was ordered due to excessive
FDA Policy/General
A House Appropriations subcommittee has voted to approve a fiscal year 2019 spending bill that would give FDA a $308 million (10%) boost above the current 2018 spending level. Under the measure, the agency would receive $3.1 billion in discretionary funding, and total funding, which includes user fees, would
Drugs
Pacira Pharmaceuticals is petitioning FDA not to approve any ANDA for a fixed-dose combination of bupivacaine and meloxicam unless the application “includes sufficient evidence from adequate and well-controlled studies, including those that use a factorial design, demonstrating the safety and effectiveness of the combination product. In particular, FDA
Drugs
FDA has issued a draft guidance, Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, with agency recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from requirements that drug distribution supply chain trading partners must
Biologics
FDA has approved a Janssen supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The agency’s decision came a few weeks ahead of the scheduled 5/21 user fee
Devices
A new FDA letter to healthcare professionals provides recommendations about patient selection and the use of neurovascular stents used for stent-assisted coiling (SAC) of brain aneurysms. The agency says it has received reports associated with the use of these devices in treating unruptured brain aneurysms that “suggest some events
Drugs
Attorney Victor Schwartz (Shook, Hardy & Bacon) says the Supreme Judicial Court of Massachusetts has clouded the question of innovator drug company liability in cases alleging injury caused by a generic drug company’s version of their product. Writing in a Washington Legal Foundation Legal Opinion Letter, Schwartz says the
Drugs
FDA has provided a target date of 8/19 for its response to a Rockwell Medical submission seeking approval of a new contract manufacturer for its approved generic drug Calcitriol vitamin D injection indicated for treating secondary hyperparathyroidism in dialysis patients. The agency indicated that the submission is getting an
Devices
Attorney Bradley Thompson (Epstein, Becker & Green) says he is hearing industry enthusiasm for FDA’s new software precertification program but not enough discussion about the program’s heavy cost to industry. “FDA wants more power. A lot more,” he writes. “And I for one am worried.” Thompson says the
Drugs
FDA has approved a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia. The label update is based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotek Inc. Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example,
Drugs
FDA says that AuroMedics Pharma is recalling two lots of ampicillin and sulbactam for injection USP 3 grams/single-dose vial to the hospital/user level due to the presence of visible particulate matter. The agency post of a company statement says the recall follows customer complaints about the presence
Drugs
FDA has hinted that it is working on a guidance on manufacturer communications about their products under the First Amendment. In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood noted that there has been great interest in the parameters of a firm’s
Devices
FDA has permitted the de novo marketing of Wilson-Cook Medical’s Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is applied during an endoscopic
Devices
FDA has approved a CardioFocus PMA for the HeartLight Excalibur Balloon, a next-generation technology for treating paroxysmal atrial fibrillation. The device, which is intended to advance the company’s technology used in its FDA-approved HeartLight Endoscopic Ablation System, introduces “an advanced feature set that optimizes the speed and
FDA Policy/General
Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities. The document was published with an incorrect docket number. The notice now is corrected to read docket number “FDA–2011–N– 0075.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The withdrawal is necessary after FDA received significant adverse comment against the proposal. The agency will now
Devices
Terumo has recalled its Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems due to revised cleaning instructions. The heater-cooler devices are used during surgeries to warm or cool patients as part of their care. Terumo took this action in response to FDA’s
FDA Policy/General
FDA has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools program. It aims to reduce regulatory burden by qualifying tools that can aid in developing and evaluating devices. Qualified tools can be used by industry to support
Drugs
Serenity Pharmaceuticals has petitioned FDA asking it to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treating nocturia. Serenity is the NDA holder for Noctiva (desmopressin acetate) nasal spray. In the petition, Serenity requests that FDA deny approval because Ferring has not
Drugs
FDA has posted an Akorn Form 483 from a 2016 inspection at the firm’s Zurich, Switzerland sterile drug manufacturing facility. The five-item 483 cited the firm for failing to thoroughly review any unexplained discrepancy. It was also cited for not having the quality control unit’s responsibilities and
FDA Policy/General
FDA Withdraws 3 Sun Pharma ANDAs Federal Register notice: FDA withdraws three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. 05/04/2018 9 No Longer Marketed ANDAs Withdrawn Federal Register notice: FDA withdraws the approval of nine ANDAs from multiple applicants. 05/04/2018 Needle Destruction Device