Devices
A new Medical Imaging & Technology Alliance (MITA) white paper, “Understanding Accountability in Medical Device Servicing,” calls on FDA to do more to hold third-party medical device servicing businesses accountable. The document gives an overview of the types of organizations and entities that perform medical device servicing and the
Drugs
CDER Office of Medical Policy (OMP) director Jacqueline Corrigan-Curay has accepted a detail to the Office of the Center Director as deputy director for operations, effective 2/14. While acting in this position, Corrigan-Curay will continue in her role as OMP director. Corrigan-Curay’s temporary move is
Drugs
The U.S. Court of Appeals for the Federal Circuit, the nation’s highest patent court, has agreed to reconsider a 10/2020 ruling that Teva says would enable innovator drug companies to block low-cost generic competition. Bloomberg Law reports an appeals court panel voted 2-1 to reopen
Drugs
A Hogan Lovells white paper, “The False Claims Act Guide: 2020 and the Road Ahead,” says that a federal directive to prioritize the investigation of coronavirus-related fraud, the unprecedented amount of federal stimulus payments, and the transition to a new administration are creating a climate in which False Claims
Biologics
Despite an all-hands-on-deck approach to address Covid-19 issues in 2020, CBER was also able to squeeze out its new CBER Advanced Technologies Team (CATT) to “address the need for a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality biologics,” according to Center
Devices
CDRH Office of Neurological and Physical Medicine Devices director Carlos Pena has left the agency to develop the newly established Office of Regulatory Services at Jacobs Institute in Buffalo, NY. The institute says its mission is to “accelerate the development of next-generation technologies in vascular medicine through collisions of
Devices
FDA has granted Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment. The in vitro diagnostic immunoassay is intended to measure Growth Differentiation Factor-15 (GDF-15) in cachectic patients 18 years of age and older with solid tumors for
Drugs
Supernus Pharmaceuticals has resubmitted its NDA for SPN-812 for treating attention deficit/hyperactivity disorder (ADHD) in pediatric patients. In 11/2020, FDA issued a complete response letter, citing Supernus’ in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus says
Drugs
FDA is urging drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient (API) due to its complex nature that makes it challenging to compound. “Remdesivir API is complex and neither a United States Pharmacopeia monograph nor other public quality standard for the API used in FDA-
Drugs
FDA has granted Ellodi Pharmaceuticals a fast track designation for APT-1011 (fluticasone propionate) oral disintegrating tablet for treating eosinophilic esophagitis, a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration in the esophagus. The designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission
Drugs
FDA has granted TG Therapeutics accelerated approval for Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon for treating adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen, and with relapsed or refractory follicular lymphoma
Drugs
A 12/17/20 meeting of FDA and industry representatives to negotiate the reauthorization of GDUFA covered these topics, according to a meeting summary distributed by the agency: * industry asked the agency to consider harmonizing some technical terminology related to the mid-cycle discipline review letters with a publicly-facing
FDA Policy/General
FDA says it is developing guidances for developers of Covid-19 diagnostics, therapeutics and vaccines to help guide their need to adapt and pivot as new variants of coronavirus (Covid-19) are identified. “We have been actively assessing the impact of new strains on authorized products and continue to work
Drugs
FDA reviewers are taking issue with a Merck study supporting a new indication for Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. FDA briefing documents released
Devices
FDA has granted a Signifier Medical Technologies de novo request to permit the marketing of a new prescription-only device, eXciteOSA, intended to reduce snoring and mild obstructive sleep apnea. “Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue
Biologics
FDA is limiting the emergency use authorization (EUA) for Covid-19 convalescent plasma after evaluating the most recent information available. “Based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020, we have revised the EUA to limit the authorization to the
Drugs
Bristol-Myers Squibb 2/5 won BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The BLA’s review was put on hold in November pending the completion of an inspection, which was
Drugs
Apotex has recalled two batches of enoxaparin sodium injection due to a packaging error resulting in some syringe barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa.
Drugs
Three Morgan Lewis attorneys say a recent FDA guidance to facilitate the development of antisense oligonucleotide (ASO) drugs for patients with severely debilitating or life-threatening genetic disorders that are tailored to a patient’s specific genetic variant is targeted to academic investigators who may be less familiar with the
Drugs
The Clinical Trials Transformation Initiative (CTTI), a joint venture of FDA and Duke University, says it has identified eight best practices for designing and conducting Covid-19 treatment clinical trials. “While these best practices, comments, and quotes are specific to Covid-19 trials, CTTI recommends that these principles should be
Devices
FDA has cleared a Precision Spine 510(k) for its Dakota ACDF Standalone System for treating degenerative disc disease (DDD). The device features a titanium plate polyetheretherketone cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion, the company says.
FDA Policy/General
An LA Times op-ed is endorsing CDER director and current FDA acting commissioner Janet Woodcock as the agency’s next leader. The piece was written by Massachusetts Institute of Technology professor Phillip A. Sharp, Friends of Cancer Research founder Ellen V. Sigal, and Sherry Lansing Foundation founder Sherry Lansing.