FDA Policy/General
Former FDA commissioner Mark McClellan and Friends of Cancer Research founder and chair Ellen Sigal say there are four things FDA can do to build on what has worked in the past and position itself for a strong future. Writing in an online Stat article, McClellan and Sigal highlight emerging
Drugs
An FDA 2/18 Warning Letter says that LeeSar, Inc., Fort Myers, FL, which registered as an outsourcing facility 4/30/14, was inspected from 7/3-7/12/17 and it was determined that the firm’s drug products failed to meet the conditions under section 503B of the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.” The document describes study designs for generating data that may support both 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Product Labeling for Laparoscopic Power Morcellators.” The document proposes updated “Contraindications” and “Warnings” in product labeling information to reflect the state of the science and available technology regarding use of laparoscopic power morcellators. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document discusses FDA’s thinking on implementing waiver improvements mandated by the section of the 21st Century Cures Act. To
Devices
CDRH is soliciting voluntary participants for a pilot of its eSTAR (Electronic Submission Template and Resource) program. A Federal Register notice says that the eSTAR pilot is voluntary and intends to improve consistency and efficiency in both industry’s preparation and FDA’s review of 510(k) submissions. The notice
Drugs
FDA has released the FDA-483 issued following a 9/9-9/26/19 inspection at Dynalabs, a St. Louis, Mo., control testing laboratory. The four inspection observations were: * failing to establish and document the accuracy, specificity, and reproducibility of test methods; * failing to have the written stability program for
Drugs
Two months ahead of its user fee review goal, FDA has approved Puma Biotechnology’s Nerlynx (neratinib) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. An FDA release
Drugs
FDA commissioner Stephen Hahn says the agency is evaluating potential regulatory pathways outside of the existing drug pathway that would allow various types of CBD products to be lawfully marketed. In a 2/26 presentation to the National Association of State Departments of Agriculture, Hahn said the agency wants to
Drugs
Healthcare performance improvement consultants Vizient says the FDA Unapproved Drugs Initiative (UDI) will increase healthcare spending by $20.25 billion. In its analysis, Vizient says UDI is an FDA mandate that unapproved drugs that have been in use prior to agency review of safety and efficacy must be approved or
Drugs
Y-mAbs Therapeutics says it will complete in 10 weeks a rolling BLA for omburtamab for treating patients with central nervous system(CNS)/leptomeningeal metastases from neuroblastoma. At a recent pre-BLA meeting, the company says it reached “alignment” with FDA on an accelerated approval pathway for omburtamab. The company
Drugs
FDA has granted Takeda Pharmaceutical Co. a priority review for a supplemental NDA that seeks to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Alunbrig
Drugs
Three industry stakeholders say further information and clarification is needed in an FDA draft guidance on the implementation of pediatric studies of molecularly targeted oncology drugs under the FDA Reauthorization Act. The Biotechnology Innovation Organization (BIO) says that while the law contemplates only one molecularly targeted pediatric investigation, the draft
Drugs
A 9/9-9/13/19 FDA inspection at the Essnd Global drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/14 Warning Letter says specific violations were: · failing to perform, for each batch of drug product, appropriate
Devices
A 9/17-10/29/19 FDA inspection at Unetixs Vascular, North Kingstown, RI, found Quality System Regulation violations in the firm’s manufacturing of vascular diagnostic ultrasound systems such as its MultiLab series of devices. A 2/4 Warning Letter says significant violations were: * failing to establish and maintain
Drugs
A 4/9-4/16/19 FDA inspection at KVK-Tech, Newtown, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/11 Warning Letter said specific violations were: * failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods;
Devices
FDA says it has taken several steps to make the use of laparoscopic power morcellators safer in gynecologic surgeries. The agency approved updated labeling for the PneumoLiner containment system that contains tissue to be morcellated during gynecologic surgery, issued a safety communication, and approved a new draft guidance. The updated
Biologics
FDA has accepted for review a Genentech BLA for a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy, for treating eligible patients with HER2-positive breast cancer. The submission is based on data from the Phase 3
Drugs
FDA has approved a Perrigo Pharmaceutical ANDA for the first generic of Teva’s ProAir HFA (albuterol sulfate) inhalation aerosol for treating or preventing bronchospasm in patients four years of age and older with reversible obstructive airway disease. It is also indicated for preventing exercise-induced bronchospasm in patients four
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biomedix, Bloomington, IN (2/12): FDA inspected the firm 10/2019 and cited GMP violations with its medical device operations. For example, the company failed to establish and maintain
Devices
FDA has cleared an Emagine Solutions Technology 510(k) for its VistaScan mobile ultrasound. The device is intended to transform a clinician’s cell phone or tablet into a portable ultrasound. The system comprises compatible FDA-cleared ultrasound probes that interface with the company’s VistaScan software application. The software’
Devices
FDA says it cleared 2/25 a new version of the LivaNova heater-cooler system 3T that has changes to help reduce the risk of patient infections, including updated labeling with validated cleaning and disinfection instruction and the 3T aerosol collection set. Announcement of the clearance was included in an