Biologics
FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency is seeking better safety measures to mitigate potential risks to blood products. In a joint statement, they say that technology exists to potentially transform the assurance of blood product safety while also potentially reducing the cost. Whether an
Devices
Public Citizen Health Research Group founder and senior advisor Sidney Wolfe says FDA should require extensive pre-approval testing of permanent implantable devices, including breast implants. Addressing the agency’s General and Plastic Surgery Device Panel 3/26, Wolfe said breast implants have caused many serious medical conditions in women,
Drugs
FDA has cleared an InControl Medical 510(k) for the Attain, described by the company as the first over-the-counter non-implantable muscle stimulator designed for at-home use to help treat women suffering with stress, urge, mixed urinary incontinence or bowel incontinence. The device provides a guided exercise
Devices
FDA has cleared a Masimo 510(k) for the Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusable Sensor. Rad-67 offers hemoglobin measurement (SpHb) and Measure-through Motion and Low Perfusion SET pulse oximetry, the company says. The device
Drugs
Stakeholders are praising FDA for its draft guidance on developing and submitting proposed draft guidance relating to patient experience data. The Biotechnology Innovation Organization (BIO) says it believes that “strong trilateral communication between FDA, patients and patient organizations, and sponsors around patient experience will result in incorporation of patient experience
Drugs
A 3/19-3/30/18 FDA inspection at the Mariposa Labs drug manufacturing facility in Boise, ID, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/14 Warning Letter says the firm also manufactured unapproved and misbranded drug products. Specific CGMP violations noted
Drugs
CDER clinical pharmacologists are helping drug developers use computational models to achieve safe and effective dosing recommendations for patients taking more than one drug. In a Regulatory Science Impact Story, CDER says physiologically based pharmacokinetic models “make it possible to simulate clinical trials that support dosing recommendations, as well as
Drugs
Celgene has submitted an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is described by the company as an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. The drug causes lymphocyte retention in
Devices
FDA commissioner Scott Gottlieb says the agency is taking steps to prevent and mitigate potential medical device shortages due to the recent closure of an Illinois sterilization facility and the likely closure of a second facility. In a statement, Gottlieb says FDA has been monitoring the situation following action by
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mariposa Labs Boise, ID (3/14): FDA inspected the firm 3/2018 and cited significant GMP violations for finished pharmaceuticals. The firm was also cited for manufacturing unidentified, unapproved
Biologics
FDA has released a final guidance on “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in
FDA Policy/General
Federal Register notice: FDA has announced a 5/8 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Chiesi USA NDA for mannitol inhalation powder, indicated for managing cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard
Devices
FDA has cleared a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. The company describes the device as a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It allows for up
Drugs
FDA has issued Sun Pharmaceutical (Gujarat, India) a three-page Form 483 after a February inspection cited GMP deviations for finished pharmaceuticals. For example, the inspection form says Sun failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
FDA Policy/General
Federal Register notice: FDA has announced a 4/25 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance “Rare Diseases: Natural History Studies for Drug Development.” The document says that a natural history study collects information about a disease’s natural history in the absence of an intervention, from the disease’s onset until either its resolution or
Devices
FDA has cleared a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions. The company describes the device as the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. It is designed to eliminate the need for a second invasive procedure.
Drugs
Bayer and Janssen Pharmaceuticals have agreed to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged serious and sometimes fatal bleeding episodes. Bayer expects its liability insurance to cover part of the settlement costs. While the companies say the claims are without merit
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Rosa One Spine System for robotically assisted spine surgeries. The device combines robotics and navigation “while delivering a unique real-time patient dynamic tracking capability,” the company says. “The platform features 3D intraoperative planning software in addition to a navigation
FDA Policy/General
Workshop on Nontuberculous Mycobacterial Disease Drugs Federal Register notice: FDA announces a 4/8 public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” 03/22/2019 Antimicrobial Drugs Advisory Committee Meeting on Bacitracin Federal Register notice: FDA announces a 4/26 Antimicrobial Drugs Advisory Committee
Drugs
FDA has issued a safety alert about cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. “Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities,” the alert
Drugs
FDA has made available a draft guide entitled “Rare Diseases: Natural History Studies for Drug Development.” The document is intended to help inform the design and implementation of natural history studies that can be used to support safe and effective drug and biological product development for rare diseases. Specifically, it