Drugs
DEVICES FDA has cleared a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). The Dietary Supplement Health and Education Act added section 402(g) on good manufacturing
Drugs
FDA has posted a 3/5 FDA 483 citing a Dr. Reddy’s Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) facility conducted 3/1 to 3/5. According to the 483, FDA found the facility’s system for reprocessing APIs and API intermediates to be insufficient. For
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Certification of Identity; Form FDA 3975” (OMB Control Number 0910-0832). The form is required when an individual making an Freedom of Information Act (FOIA) request or Privacy Act request for records about the person and he/
Devices
FDA has released a guidance on “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (Covid-19) Public Health Emergency (Revised).” The document outlines a revised policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95
Devices
FDA has granted Becton, Dickinson and BioGX an emergency use authorization for a new diagnostic test that will enable hospitals to screen for Covid-19 ) on site and get results in under three hours. The test will be run on the BD Max System, a molecular diagnostic platform already in
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Special Protocol Assessments.” A guidance under the same title describes procedures for sponsors to request special protocol assessments and for FDA to act on such requests. It provides information on how FDA interprets and applies provisions that
Drugs
FDA has posted a 15-item FDA 483 issued 2/25 to Shilpa Medicare following an inspection of the firm’s Telangana, India drug manufacturing facility. The February inspection cited the company over its quality unit. For example, the unit failed to ensure that all production and laboratory control operations
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from Class 3 (product codes MZP and OBF) to Class 2 (general controls and special controls), subject to premarket
Devices
An 11/4-11/7/19 FDA inspection at Okamoto Rubber Products, Klongluang, Pathumthani, Thailand, found Quality System Regulation violations in the firm’s production of lubricated natural rubber condoms. A just-released 2/14 Warning Letter says specific violations were: * failing to adequately ensure that when the results of
Devices
A 10/22-10/25/19 FDA inspection at E-Care Technology, Chubei City, Taiwan, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of the Swaive thermometer. A just-released 3/2 Warning Letter says specific violations were: * failing to establish and maintain design
Drugs
FDA has granted an emergency use authorization to Cellex for a coronavirus serology test. The assay is intended for use in CLIA-certified laboratories for detecting Covid-19 antibodies in blood samples. The test could help detect those who have previously been infected and had few, if any, symptoms. "
Drugs
FDA has approved a Celularity IND for its investigational stem cell therapy in Covid-19 patients. The company says it is planning a Phase 1/2 clinical study of CYNK-001 in 86 patients with Covid-19. The therapy has been at the center of a campaign directed by president
Drugs
FDA has released the FDA-483 issued following a 2/10-2/21 inspection at Biocon Sdn Bhd, a biotech firm in Johor, Malaysia. The three inspection observations were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failing to establish and follow
Devices
FDA has announced a 5/5 public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027” that will be available by Webcast. The meeting is scheduled to discuss proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. To
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV from Class 3 (product code MZO) to Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation
Drugs
The International Council on Harmonization is issuing a notification to users of the Medical Dictionary for Regulatory Activities (MedDRA) about existing and new terms for coronavirus concepts. The document says the Covid-19 pandemic “has prompted an urgent need for a harmonized standardized approach to coding and reporting the infection
Drugs
FDA has released the FDA-483 with 10 observations from a 3/2-3/10 inspection at Immunomedics, Inc., a Morris Plains, NJ, drug substance intermediate manufacturer. The observations were: * failing to establish procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related components; * failing
Drugs
FDA has given Vanda Pharmaceuticals approval to begin a clinical study, ODYSSEY VLY-686-3501, of tradipitant in hospitalized patients with Covid-19. The Phase 3 study will evaluate the therapy in treating and preventing pneumonia associated with Covid-19. It will randomize about 300 New York-area hospital patients
FDA Policy/General
Federal Register notice: FDA has amended its medical device regulations to reflect changes to CDRH’s organizational structure, including the reorganization of its offices. The revisions replace references to the obsolete offices and positions with the current information, update the physical addresses for such offices, and correct inaccurate citations. To
FDA Policy/General
Federal Register notice: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during the first quarter of this fiscal year. The agency is also making available summaries of the basis of approval and environmental review documents,
Drugs
A 3/30 Wiley Rein petition asks FDA to withdraw or rescind its 2/14 approval of a supplemental NDA switching GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium) topical gel 1% from Rx only to over-the-counter status. The petition says the OTC switch should be rescinded because “important