FDA Policy/General
Federal Register notice: FDA has announced a 7/18-19 Blood Products Advisory Committee. On the first day of the meeting, panel members will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day, the panel and members from
Devices
FDA has cleared a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system. The rapid automated diagnostic system uses an advanced laser sensor to detect infections, reducing lab turnaround time to about three hours, an improvement of up to 90% compared with traditional testing approaches, according to the
Devices
FDA has cleared a Caliber Imaging & Diagnostics 510(k) for modifications to its Vivascope System, a reflectance confocal microscopy (RCM) device that allows dermatologists to visualize cellular structures within the skin. The device provides high-resolution RCM images of the epidermis down to the supporting stroma in thin, optical
Biologics
FDA has approved a Hospira BLA for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgen’s Epogen/Procrit (epoetin alfa) for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulations concerning the classification of products as biologics, devices, drugs, or combination products, and their assignment to agency components for premarket review and regulation. This proposed rule would update combination product regulations to clarify their scope, streamline and clarify the
Drugs
The University of Illinois at Chicago College of Pharmacy says there are steps FDA could take to expedite entry of biosimilars into U.S. markets. In a 5/11 petition, the school says that since passage of the Biologics Price Competition and Innovation Act in 2009, FDA has licensed only
Drugs
Three stakeholders are raising questions about proposed FDA research surveying healthcare professionals on prescription drug promotion. Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency has not followed Paperwork Reduction Act (PRA) procedures that require it to provide adequate means to request and obtain a copy of the survey.
FDA Policy/General
Federal Register notice: FDA has announced a 7/9 public meeting on “Patient-Focused Drug Development for Chronic Pain” that is intended to provide patients with an opportunity to present their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to
FDA Policy/General
Federal Register notice: FDA has announced a Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting 6/20 to review and discuss a list of molecular targets for which evidence or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric
Drugs
A 10/30-11/3/17 FDA inspection at Reine Lifescience, Gujurat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 5/9 Warning Letter saysthat specific deviations were: * failing to validate and verify the auditability of analytical methods; * failing to exercise sufficient controls
Drugs
A 10/2-10/6/17 FDA inspection at Ei LLC, Kannapolis, NC, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a just-released 4/16 Warning Letter. Specific violations were: · failing to maintain adequate separate defined areas necessary to prevent contamination or mix-
Drugs
In preparation for the August distribution of PDUFA 6 FY 2019 program fee invoices, FDA has contacted drug manufacturers outlining policy changes under PDUFA 6 and seeking updated contact information. Policy changes described in the document affect (1) what prescription drug products are considered to be the “same product as
Devices
FDA says currently available objective evidence is not sufficient to conclude whether there is a widespread public health concern related to servicing of medical devices that would justify imposing additional or different burdensome regulatory requirements at this time. That position is stated in a 5/2018 agency report on the
Devices
Serious security flaws were found in Philips, GE, and Silex medical devices that, if exploited, could allow unauthorized access and let a hacker obtain elevated privileges, according to two HHS cybersecurity alerts. Healthcare IT News outlines the issues raised in the HHS reports and company actions to resolve them.
Drugs
The Supreme Court of Appeals of West Virginia says there is no cause of action in the state for failure to warn and negligent misrepresentation against a brand-name drug manufacturer when the drug taken by a plaintiff was produced by a generic drug company. The court issued its 5/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Product Quest MFG, Daytona Beach, FL (4/16): FDA inspected the firm 10/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to maintain
FDA Policy/General
Federal Register notice: FDA has made available a draft entitled “Pediatric HIV Infection: Drug Development for Treatment.” The document provides general recommendations on developing such drug products, including when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for treating HIV infection. To view
FDA Policy/General
Federal Register notice: FDA has announced a partial withdrawal of a proposed rule published in the 8/21/2003 Federal Register that would have amended the agency’s tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products to include ibuprofen as generally recognized
Drugs
FDA has cleared a Baxter International 510(k) for the Spectrum IQ Infusion System with Dose IQ Safety Software. The device is designed for bi-directional electronic medical records integration with new features to help ensure the correct medications and fluids are delivered to each patient. Baxter says it provides
Drugs
FDA has approved a UCB supplemental NDA for Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in treating partial onset (focal) seizures in patients age four years and older. The expanded indication is based on extrapolation of efficacy data from adults to children, and is supported by
Devices
FDA has granted Immunicom a breakthrough device designation for its Immunopheresis therapy, which is based on a proprietary technology that selectively removes immune inhibitors from patients’ bloodstreams and thus enables their natural immune system to more-effectively attack cancer tumors. “By removing immune system inhibitors from the blood without introducing
FDA Policy/General
“The secretary of HHS has a shocking amount of power by the stroke of a pen, and we intend to exercise it,” HHS secretary Alex Azar told PBS News Hour 5/14, addressing the cost of prescription drugs paid by Medicare for senior citizens − an issue FDA commissioner Scott Gottlieb