Devices
FDA has cleared an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that the company says features a “modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde orientations with a dedicated instrumentation kit.” It offers several versatile
Biologics
HHS says it has canceled an FDA contract with Advanced Bioscience Resources to provide human fetal tissue used to develop drug testing protocols. In a brief statement, the department said it was “not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all
Devices
FDA has cleared a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass that is, according to the company, dimensionally integrated within a collagen and sodium hyaluronate scaffold. The device’s porosity was specifically designed for optimized absorption of bone
Drugs
Researchers from the Institute for Safe Medication Practices and several academic medical centers say that the cost of pivotal clinical trials required by FDA to provide substantial evidence of efficacy for new therapeutic agents increases if more patients are needed to document treatment benefit, if active drug comparators are used,
Drugs
A 2/26-3/1 FDA inspection at Wilson Medicine Co., Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/11 Warning Letter. Specific violations cited in the letter were: * failing to establish written procedures for production and process control
Drugs
FDA has released one draft and two final guidances relating to aspects of drug compounding. The draft guidance, Insanitary Conditions at Compounding Facilities, describes examples of insanitary conditions observed by FDA at drug compounding facilities. The document specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing
FDA Policy/General
Federal Register notice: FDA has announced an opportunity for public comment on an information collection extension entitled “Generic Drug User Fee Cover Sheet.” To view the notice, click here.
Drugs
CDER Office of Process and Facilities branch chief Ying Zhang recently presented (see slides) common issues and deficiencies cited during pre‐approval drug inspections. Speaking at the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD 9/20, Zhang listed the deficiencies and they include: * Inconsistencies between facility
Drugs
In an amicus brief submitted to the Supreme Court, Washington Legal Foundation (WLF) says the court should decide that federal law preempts a state law failure-to-warn claim in cases where it can be shown that FDA rejected a drug manufacturer’s request to change its label to include
Drugs
CDER Division of Biometrics IV director Dionne Price says FDA will publish draft guidances and develop or revise relevant Manuals of Policies and Procedures, standard operating procedures, and/or review templates to support increasing use of complex innovative trial designs (CIDs). In a CDER Conversation, Price says the guidances will
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Wilson Medicine Co. Nandore, India (9/11): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For
FDA Policy/General
Federal Register notice: FDA has reopened the comment the comment period provided in a 2/16 notice entitled “Pediatric Medical Device Development; Public Meeting; Request for Comments. ” Comments now can be accepted until 11/26. To view the notice, click here.
Drugs
FDA has released one draft and two final guidances relating to aspects of drug compounding. The draft guidance, Insanitary Conditions at Compounding Facilities, describes examples of insanitary conditions observed by FDA at drug compounding facilities. The document specifically addresses drugs, including biological products, produced by pharmacies, federal facilities, and outsourcing
FDA Policy/General
Federal Register notice: FDA has set the fee rate for using a tropical disease priority review voucher at $2,456,140 for fiscal year 2019. The fee is in addition to any drug user fee that is required for such an application. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class 3 device (regulated under product code LZR) into Class 2 (special controls), subject to a premarket notification 510(k) submission. This device is indicated for treating refractory glaucoma; it is intended for
FDA Policy/General
FDA has posted a draft guidance entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.” The document is intended to provide recommendations to industry and review staff to ensure that the review process is managed in a consistent and efficient manner, thereby decreasing the
Drugs
FDA has released a final guidance entitled “ANDA Submissions — Content and Format” that details the information that should be provided in each section of the common technical document format. The document also identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. Additionally,
Drugs
In recognition of recent court decisions that have been protective of off-label promotion, CDER director Janet Woodcock has acknowledged that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement. Addressing an Alliance for a Stronger FDA gathering in Washington, DC 9/21, Woodcock was asked
FDA Policy/General
Federal Register notice: FDA has announced an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations on the topic “Connected and Empowered Patients: E-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media
Drugs
CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent director for the Office of New Drugs (OND). Woodcock has been overseeing OND since former director John Jenkins retired 1/2017. His departure became controversial after he made it clear that
Drugs
FDA has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical products for patients with rare diseases. The funding helps support early-stage development activities targeting rare diseases that don’t have effective treatments. “By providing seed capital,
Devices
FDA has issued a final guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics” that is intended to promote consistency, predictability, and transparency in the device submission review process when determining substantial equivalence for devices that have different technological