Drugs
A 3/27-4/3/18 FDA inspection at Pfizer’s Hospira Healthcare India drug manufacturing facility in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/4 Warning Letter says the specific violations were: * failing to ensure that laboratory records
Drugs
HHS secretary Alex M. Azar III has appointed National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlieb leaves next month. Gottlieb announced his resignation to spend more time with his family (see earlier story). Sharpless previously served as director of the University of
Devices
GE Healthcare says the concept of the FDA software precertification program “maintains FDA’s gold standard in ensuring safety and effectiveness of software medical devices, while providing faster access to market for software devices developed by trusted pre-certified organizations.” The company says that accelerated pathway is crucial in helping
FDA Policy/General
The Justice Department says Covidien has agreed to pay $17,477,947 to resolve whistleblower allegations it violated the False Claims Act by providing free or discounted practice development and market development supports to doctors in California and Florida to induce purchase of the company’s vein ablation products. The
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Anicare Pharmaceutical Mumbai, India (2/28): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Anicare failed to establish and follow an
Drugs
FDA has approved an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The agency says it prioritized the submission’s review to “help relieve the recent shortage of this critical medicine as a result
Drugs
FDA has released the FDA-483 issued following a 2/7-2/15 inspection at Biocon Limited, a Bangalore, India, drug product manufacturer. The two inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, adequately validated, and/or followed;
Devices
FDA has qualified the OsiriX CDE software module from the TBI Endpoints Development Initiative as the first biomarker test tool type to be qualified. The agency says it is the third medical device development tool (MDDT) it has qualified. The qualification is said to provide a tool for more efficient
Drugs
FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids, the company
Devices
Integra LifeSciences says that a subsidiary 3/6 received an FDA Warning Letter blocking PMA approvals due to quality systems issues at a Boston manufacturing facility. The facility manufactures extracellular bovine matrix products. The letter was based on finding from a 11/2018 inspection and mirrored Form 483 observations that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Export of Medical Devices; Foreign Letters of Approval” (OMB Control Number 0910-0264). Written authorization must be obtained from the appropriate office within a foreign government approving the importation of a medical device. An alternative to obtaining written
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The agency guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking
FDA Policy/General
Federal Register notice: FDA has made available a model Drug Facts label for nonprescription naloxone, indicated for treating opioid overdose. The agency is making the label and supporting data available for use by applicants seeking approval for naloxone drug products that can be obtained without a prescription. To view the
Drugs
The Trump Administration has proposed a 7% boost ($419 million) in FDA’s 2020 budget, which includes more than $220 million to continue advancing new initiatives that will promote medical product innovation. An agency release says that the additional resources would “help the agency combat the opioid epidemic; advance new
Drugs
CytoDyn says it is seeking fast track status for its humanized CCR5 monoclonal antibody, leronlimab (PRO 140), after it showed a significant reduction in the volume of human breast cancer tumor metastasis in a murine xenograft model. “The metastatic tumor volume was reduced by more than 98% after seven weeks,
Devices
FDA has granted Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and therapy infusion (intrathecal bolus administration). The company says the device is indicated for patients aged three years and above who
FDA Policy/General
Comments Sought on Info Collection for CDRH Appeals Federal Register notice: FDA seeks comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes.” 03/08/2019 New Info Collection on Bio Product Name Suffix Federal Register notice: FDA seeks comments on a new information collection
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The agency guidance describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. FDA is seeking
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection for “Proposed Suffix for the Proper Name of a Biological Product.” The collection is related to a final guidance on “Nonproprietary Naming of Biological Products,” which recommends that applicants propose a suffix composed of four lowercase letters to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonproprietary Naming of Biological Products: Update.” The document describes FDA’s current thinking on biologic product nonproprietary names that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish
FDA Policy/General
FDA is seeking comments on a new information collection related to a proposed “Healthcare Professional Survey of Professional Prescription Drug Promotion.” The survey’s goal is to learn healthcare professionals’ (HCPs) opinions on promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. Additionally,
Devices
FDA has issued a letter to health care providers to alert them to an increasing number of medical device reports associated with surgical staplers for internal use and implantable surgical staples. In the coming months, CDRH will issue a draft guidance with safety labeling recommendations for manufacturers, according to a