Drugs
Amgen says an FDA draft guidance on adjusting for covariates in randomized clinical trials for drugs and biologics with continuous outcomes is easy to read and concise. In a comment letter, the company says it would be useful to add recommendations on how stratification variables should be handled, more detailed
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ecometics, Norwalk, CT (4/16): FDA inspected the firm’s drug manufacturing facility 9/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Drugs
FDA has published the International Conference on Harmonization E9 guideline, Optimization of Safety Data Collection. The document says it is intended to provide internationally harmonized guidance on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a
Biologics
FDA has accepted for priority review a Novartis BLA for its investigational sickle cell drug crizanlizumab. The submission seeks approval for preventing vaso-occlusive crises (VOCs) in patients with sickle cell disease. Novartis says that VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic
Devices
Stakeholders say they support an FDA proposal to reclassify internal surgical staplers as Class 2 devices and to implement uniform special controls as part of the reclassification. In a letter commenting on an agency draft guidance, Medtronic says that conducting additional bench and animal testing on devices that have been
Drugs
FDA has approved Teva Pharmaceutical Industries’ AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. The product is indicated for treating
Devices
FDA has announced two “innovation challenges” to encourage the development of new approaches to device sterilization. They are: Challenge 1: To identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide. Challenge 2: To develop strategies or technologies to reduce emissions to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry on Hypertension Indication: Drug Labeling For Cardiovascular Outcome Claims” (OMB Control Number 0910-0670). The collection encourages the submission of supplemental labeling and is intended to assist applicants in developing labeling for outcome
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ NDA for Miochol (acetylcholine chloride intraocular solution), 20 mg/vial, was not withdrawn from sale due to safety or effectiveness issues. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met.
Drugs
FDA tends to be more restrictive than its advisory committees when approving new products, new supplemental indications and new safety changes, according to New York University School of Medicine and Yale School of Medicines writing in Milbank Quarterly. A new study has examined advisory committee meetings where FDA and panel
Drugs
FDA has issued AstraZeneca a complete response letter on a supplemental NDA for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in adult patients with Type-1 diabetes, when insulin alone does not provide adequate control. The drug was recently approved in Europe and Japan for
Devices
FDA has cleared a LivaNova 510(k) for its LifeSPARC system, a new circulatory support pump and controller, intended for use in providing temporary support for emergent rescue patients in a variety of settings. The device includes four specialized and ready-to-deploy kits, each designed to support diverse cannulation
Devices
FDA has approved an Abbott PMA for its fourth-generation MitraClip, a heart valve repair device to treat mitral regurgitation. The latest version includes an expanded range of clip sizes, an alternative leaflet grasping feature and real-time procedure assessment to offer doctors further options when treating mitral valve disease,
FDA Policy/General
DEVICES FDA has cleared an InvisionHeart 510(k) for its Invision ECG System that is intended to provide a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic-quality electrocardiograms. T FDA has cleared RegenScientific’s Renu
FDA Policy/General
AstraZeneca says that the SOCRATES trial that assessed the efficacy of Brilinta/Brilique (ticagrelor) compared with aspirin in patients with acute ischemic stroke or transient ischemic attack missed its primary endpoint of time to first occurrence of any event from the composite of stroke, heart attack, and death. “Fewer events
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Population Pharmacokinetics (PK)” that is intended to assists sponsors in applying PK during drug development. It provides FDA’s current thinking on the data and model requirements for population PK analyses submitted in NDAs/BLAs. The guidance also provides
Drugs
Altaire Pharmaceuticals has recalled numerous brands of over-the-counter eye drops sold at CVS Health due to sterility concerns. A recall notice says that the concerns involve “the sufficiency of quality assurance controls over critical systems in the manufacturing facility.” FDA has determined that the issues indicate a lack
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.” The document describes FDA’s current thinking on key design considerations for these trials to help with development of such products for contraception. However, it does not
Drugs
Hamilton Medical has recalled its Hamilton-G5 Ventilators due to the potential for “panel connection lost” error messages to be displayed and resulting in the ventilator to stop working and enter an ambient state. “When the ventilator enters an ambient state, the patient breathes room air unassisted and the ventilator
Devices
FDA has issued a Warning Letter to Abington Memorial Hospital’s institutional review board after a bioresearch monitoring inspection found violations. For example, FDA said the IRB failed to review proposed research at convened meetings at which a majority of members of the IRB are present. The IRB was also
Devices
GE Healthcare has recalled its Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle. If an infant comes in contact with
Drugs
FDA has cleared an Icotec 510(k) for the Vader One pedicle screw system for use in both minimally-invasive and open spine surgical procedures. The device, which is made from Icotec’s BlackArmor carbon/PEEK (polyetheretherketone) material, was designed for “secure stabilization and post-operative visualization, which is important