Devices
The NEST (National Evaluation System for health Technology) Collaborative Community has issued a draft white paper, “Achieving Unique Device Identifiers in Real-World Data Sources: A Playbook for Health System Unique Device Identifier Implementation at the Point of Care.” The paper says it is intended to augment real-world evidence
Drugs
GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis (TB). “These results demonstrate the potential for GSK3036656 to be
Drugs
FDA has approved an expanded use for GE Healthcare’s DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies (DLB). Previously, the radiopharmaceutical was approved for use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of
Drugs
FDA has issued a five-item Form FDA-483 after conducting a pre-approval inspection of Lupin’s Nagpur, India Unit-2 injectable manufacturing facility 10-17-29. “We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S.,” the company
Drugs
Some 165 organizations representing healthcare providers, public health professionals, scientists, patients, and the biotech and diagnostics industries are urging lawmakers to advance the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act (H.R. 3932) before the 117th Congress ends 1/3/23. “With its power to jump-start the
Drugs
An analysis by the Germany-based ECA Academy of 42 FY 2022 FDA Warning Letters has identified the top 10 most frequently cited good manufacturing practice deficiencies. The 10 listed are: * responsibilities of the quality control unit (cited in 23 letters); * product record review (19 citations); * testing and release for
FDA Policy/General
Federal Register notice: FDA has issued an order debarring David Elias Mendoza for five years from importing or offering for import any drug into the U.S. The agency says the debarment is based on its finding that Mendoza engaged in numerous instances of importing or offering for import misbranded
Devices
FDA and MITRE have updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which the two organizations first published in 2018. An agency announcement says the playbook focuses on preparedness and response for medical device cybersecurity issues that affect a medical device’s functionality. MITRE says (includes links
Drugs
FDA has published in the Federal Register a preliminary assessment indicating that certain naloxone products have the potential to be safe and effective for over-the-counter use to counteract opiod overdose. The notice is intended to help facilitate the development and approval of certain nonprescription naloxone drug products, an
Drugs
In a briefing document released in advance of an 11/16 meeting of the Cardiovascular and Renal Drugs Advisory Committee, FDA medical reviewers continue to raise questions about the Ardelyx NDA for tenapanor to control serum phosphorous in adults with chronic kidney disease on dialysis. The document says the agency
Devices
FDA has announced a 12/7 public workshop on “Appropriate Use of Consensus Standards” to obtain public input on using them in premarket submissions for medical devices. The agency also plans to discuss “potential approaches to help facilitate the use of standards in premarket submissions,” according to a notice. Additionally,
Drugs
FDA has released the form FDA-483 issued following a 9/8-9/16 inspection at Athenex Pharma Solutions, a Clarence, NY, outsourcing facility. The one inspection observation listed was the failure to thoroughly review the failure of a batch or any of its components to meet any of its
Drugs
Amazon Web Services says it supports the intent of an FDA draft guidance on computer software assurance for production and quality system software and makes several recommendations “to strengthen and accelerate the use of technology for quality improvement.” The company recommends: * reissuing the guidance to apply across the entire agency
Devices
AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the document. The guidance was issued to help ensure that information is available to patients and healthcare professionals about the benefits and risks of LASIK devices that are used in
Devices
FDA has issued Roche Molecular Systems an emergency use authorization (EUA) for its cobas MPXV monkeypox test. The test, which is intended to be run on the company’s cobas 6800/8800 systems, is authorized for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from
Devices
FDA has cleared a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries. The device displays patient CT and MRI images as three-dimensional holograms in AR headsets, “helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the
Biologics
Protalix BioTherapeutics and Chiesi Global Rare Diseases have resubmitted a BLA for PRX–102 (pegunigalsidase alfa) for treating adult patients with Fabry disease. The companies describe pegunigalsidase alfa as a purposefully-designed, long-acting recombinant, PEGylated, cross-linked α-galactosidase-A investigational product candidate. Last year, the agency issued a
Drugs
Roche says results from two Phase 3 studies evaluating Alzheimer’s therapy gantenerumab were not statistically significant in slowing clinical decline. “Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 (p=0.0954), and -0.19 (p=0.2998)
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Referencing the Definition of a Device in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.” The document is intended to clarify the terms “device” and “counterfeit device” in guidance, regulatory documents,
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Merck’s Prevymis (letermovir) intravenous solution, indicated for prophylaxis of cytomegalovirus (CMV) infections and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The regulatory review period is 3,157
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.” The International Council for Harmonization describes risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the
Drugs
Satsuma Pharmaceuticals says topline results from the STS101 SUMMIT Phase 3 efficacy trial showed numerical differences in favor of its migraine drug STS101 5.2 mg versus placebo, but they did not achieve statistical significance. It says the favorable differences were related to the pre-specified co-primary endpoints of