Drugs
Three Harvard University professors and two Zuckerman attorneys who used to work at HHS say FDA should use the GDUFA 3 reauthorization negotiations to “balance the need to ensure sustainability with the goal of providing a level playing field for competition among firms of all sizes.” Writing in Health Affairs,
Devices
FDA has selected Intertek as an accredited testing laboratory under the agency’s Accreditation Scheme for Conformity Assessment Pilot Program. With the selection, 12 affiliates within Intertek’s global lab network are authorized to help manufacturers around the world with medical device premarket testing to access the U.S market,
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP), Critical Path Innovation Meetings, to delineate the roles and responsibilities of CDER staff and outline the procedures to be followed for a critical path innovation meeting (CPIM). The MAPP defines a critical path innovation meeting as a nonbinding scientific dialog
Drugs
Merck says it is stopping development of MK-7110 (formerly known as CD24Fc) for treating hospitalized patients with Covid-19 due to additional FDA data requests. Merck received the therapy in a 12/2020 acquisition of OncoImmune. Previously, the company and the U.S. government penned a $356 million deal
Drugs
FDA has granted priority review status to a BioMarin NDA for vosoritide, an analog of C-type natriuretic peptide in children with achondroplasia, described as the most common form of short stature in humans. The agency granted priority review based on the serious pediatric indication the drug addresses, BioMarin says.
Drugs
FDA’s willingness to embrace technology-enabled tools to conduct remote inspections and trim the mounting inspection backlog during the Covid-19 pandemic “may transform FDA’s inspection approach for years to come.” That’s the projection made by Sheppard Mullin attorneys Allison Fulton and Eva Schifni in their analysis
Devices
FDA has lifted a partial clinical hold against a Panbela Therapeutics Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treating patients with metastatic pancreatic ductal adenocarcinoma. Panbela says that due to recently observed serious visual adverse
FDA Policy/General
Federal Register notice: FDA and HHS are withdrawing a 1/15 notice that proposed exemptions for 83 Class 2 devices and one unclassified device from 510(k) premarket notification requirements. The agency says the previous administration did not consult with, involve or notify it before issuing the notice. Some of
Devices
FDA has granted Qorvo an emergency use authorization for the Qorvo Omnia SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of Covid-19. The diagnostic uses high-frequency
Drugs
The operators of Genesis Herb, an Ohio dietary supplement manufacturing company, intend to plead guilty in federal court to charges of failing to register a food manufacturing facility and refusing an FDA inspection. A Department of Justice statement says Shane Cotterill, Monroeville, OH, was charged with three counts of failing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Premarket Notification for a New Dietary Ingredient” (OMB Control Number 0910-0330). Under agency regulations, a manufacturer or distributor of a new dietary ingredient (NDI), or of the dietary supplement that contains the NDI, must submit a
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR part 315” (OMB Control Number 0910-0409). FDA regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of: (1)
FDA Policy/General
Federal Register notice: FDA is issuing an order permanently debarring Mark Reinhard from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Reinhard was convicted of a felony related to his pharmacist role at
Drugs
The ALS Association (ALSA) says FDA should follow its guidance and emulate the urgency shown by Health Canada and the European Medicines Agency to work with Amylyx to move its AMX0035 treatment toward approval. The association says AMX0035 “is a clinically safe drug that slowed disease progression and increased survival.
Devices
CDRH has posted new modules on its multi-media Web page CDRH Learn. The Center says learning modules describe many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics. The tool is intended to provide industry with information that is comprehensive, interactive, and easily
Biologics
CBER says it plans to issue guidances on 16 topics listed in four categories during the calendar year 2021. The categories are Blood and Blood Components (seven guidances); Tissues and Advanced Therapies (seven guidances); Vaccines (one guidance); and Other (one guidance).
Drugs
FDA granted accelerated approval 4/13 to Immunomedics’ Trodelvy (sacituzumab and govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. An agency notice says Trodelvy’s safety and efficacy
Drugs
FDA has published an immediately effective guidance describing how the agency will request and conduct remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic
FDA Policy/General
[Report by David McFarland] As FDA looks ahead to life after the pandemic, recovery phase planning is already underway to prioritize facility surveillance and inspections. Speaking on a 4/14 Alliance for a Stronger FDA Zoom update, acting FDA commissioner Janet Woodcock said surveillance and inspections will be boosted by
Devices
FDA has cleared an expanded indication for the use of the Avitus Bone Harvester technology to debride and capture infected, necrotic, or diseased cancellous bone, such as in the removal of osteomyelitis and cancellous bone tumors. Avitus Orthopaedics says the device is a suction-powered surgical instrument that enables surgeons
Drugs
At a meeting with CorMedix and its DefenCath (taurolidine/heparin catheter lock solution) third-party manufacturer, FDA and the firm agreed to a protocol for a manual extraction study identified in a complete response letter the agency had issued. The agency is requiring the study as confirmation of in-process
Biologics
FDA and CDC are recommending a pause in using the Johnson & Johnson (Janssen) Covid-19 vaccine due to concerns about potential blood clots in those getting the vaccine. So far, almost 7 million vaccines have been administered in the U.S. and six cerebral venous sinus thrombosis cases have