Devices
FDA has cleared a Lumendi 510(k) for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. “Adequate tissue manipulation and traction, combined with effective cutting, dissecting and cauterizing, continues to be
Drugs
A 10/31-11/3/17 FDA inspection at Europharma Concepts, County Offaly, Ireland, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/16 Warning Letter. Specific violations cited in the letter were: * failing to test samples of each component for conformity
Devices
Attorneys Gregory Levine and Abram Barth (Ropes & Gray) say that an FDA 4/27 draft guidance “provides insight into how FDA conceives of its authority to regulate multiple function devices consistent with the 21st Century Cures Act.” They say the document may be useful not only for manufacturers of
Devices
FDA is reminding healthcare professionals involved in surgical procedures about the risk of surgical fires on or near patients. The agency safety notice includes recommended practices to reduce fires from occurring, including the safe use of medical devices and products commonly used during surgical procedures. The notice says that although
Drugs
FDA has issued a guidance, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment, to assist sponsors in clinical development of drugs to treat complicated intra-abdominal infections (cIAI). The document specifically addresses the agency’s thinking on the overall development program and clinical trial designs for drugs to support an
Devices
FDA has opened a docket to receive feedback from stakeholders on provisions of the 21st Century Cures Act that exclude certain medical software functions from the definition of a medical device. Under that law, the agency says, Congress excluded specific types of software from FDA regulation, including general wellness software
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Europharma Concepts Clara Tullamore, Ireland (5/16): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to test samples
FDA Policy/General
Guide on Anthrax Prevention Drugs Federal Register notice: FDA makes available a guidance entitled ‘‘Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.’’ 05/24/2018 Comments Sought on Study Design for Heartworm Drugs Federal Register notice: FDA seeks comments as it evaluates current thinking about the design of studies intended
Drugs
DEVICES FDA has cleared an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot. “Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on
Drugs
FDA has approved a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria (PKU), a rare and serious genetic disease where patients are born with an inability to break down phenylalanine, present in protein-containing foods and high-intensity sweeteners used in a variety of foods and beverages.
Devices
FDA has cleared a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the peripheral arterials. The company says this allows physicians to select between both of XableCath’s designs (blunt or abrasion tips) to slide past an occluding
Devices
FDA has granted Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to locate wrist fractures in adult patients. The software uses an artificial intelligence algorithm to analyze two-dimensional X-ray images for signs of distal radius fracture, a common
Drugs
FDA has granted Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa (DEB). The company says that KB103 is the first topically-applied herpes simplex virus based gene therapy engineered to deliver a human collagen protein to patients suffering from DEB, which is a chronic and
Drugs
FDA has granted Pfizer a breakthrough therapy designation for tafamidis for treating patients with transthyretin cardiomyopathy, a rare and fatal condition associated with progressive heart failure. The designation was based on data from the tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, in which the drug demonstrated a statistically significant
Drugs
FDA has accepted for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain for adult patients in medically supervised settings. FDA has assigned a user fee review action target date of 11/3. In 10/2017, the agency issued
Biologics
FDA has accepted for review a Bio Products Laboratory supplemental BLA for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary factor X deficiency. The submission is based on data from TEN02, a Phase 3 prospective study. The primary endpoint was the investigator’s assessment of overall efficacy, “which
Drugs
The Supreme Court is refusing to hear an appeal of a 5th Circuit Court of Appeals decision to uphold summary judgment and award costs in favor of Solvay Pharmaceuticals in a False Claims Act case. Attorneys Jennifer Thomas and Andrew Hull (Hyman, Phelps & McNamara) write in their firm’s
Drugs
FDA has issued a complete response letter to Recro Pharma for the NDA on its IV meloxicam. The company reports that FDA said that although the pivotal Phase 3 trials demonstrated statistically significant outcomes on the primary endpoint, the agency is unable to approve the NDA in its current form.
Drugs
Pfizer will pay $23.85 million to resolve claims that it used a foundation to pay copays of Medicare patients taking three company drugs. A Justice Department news release on the settlement identifies the Pfizer drugs as Sutent and Inlyta, which both treat renal carcinoma, and Tikosyn, which treats arrhythmia
Drugs
A Senate Appropriations Committee 5/24 mark-up for FY 2019 has approved $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, but about $150 million less than the House has approved (see earlier story). Both measures are now awaiting
Devices
FDA has cleared a Mauna Kea Technologies 510(k) for the Cellvizio 100 series F400 and F800 multidisciplinary confocal laser endomicroscopy platform for use during neurosurgical procedures. The device features CranioFlex that provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled ‘‘Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.’’ The document is intended to assist sponsors in developing new drugs for the prophylaxis of inhalational anthrax. It finalizes a draft guidance issued on 3/2016. To view the notice, click here.