FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes FDA’s current recommendations for dietary management in clinical trials for drugs intended to
Drugs
FDA has accepted a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. The agency has set a user fee review action target date in the first quarter
Drugs
FDA says it wants more applicants to participate in its Parallel Scientific Advice (PSA) pilot program for complex generic/hybrid drug products. In an agency podcast, CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says PSA allows applicants to engage in concurrent scientific conversation
FDA Policy/General
Federal Register notice: FDA has announced a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss new data on the “Generally Recognized as Safe and Effective” status of oral phenylephrine as a nasal decongestant that have become available since the agency last examined the issue. To view the notice,
Drugs
ADC Therapeutics has paused new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma after reporting seven patient deaths. The action followed a recent review of aggregate data of
Drugs
Genentech says an FDA draft guidance on incorporating clinical outcome assessments into endpoints for regulatory decision-making “marks a critical milestone as the final installment in FDA’s patient-focused drug development (PFDD) methodological guidance series that aims to describe a sustainable path to incorporate patient input as data in
Devices
Megadyne is recalling its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of pediatric and adult patients receiving burns. “These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes the Advanced Manufacturing Technologies Designation Program discussed at an FDA 6/8 workshop on advancing the use and supporting the implementation of innovative manufacturing approaches “has the potential to further the use of advanced manufacturing technologies that can, in turn,
Devices
FDA says that as a result of additional data and analyses, it now no longer believes there is an excess mortality risk for paclitaxel-coated devices used to treat peripheral arterial disease. An agency 7/11 letter to healthcare providers reverses the announcement in a 1/17/2019 letter of
Drugs
FDA has published a draft guidance, Inborn Errors of Metabolism that Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development, with recommendations for optimizing and standardizing dietary management in clinical trials for developing drugs that treat inborn errors of metabolism for which dietary
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Emergency Use Authorization of Medical Products and Related Authorities.” The collection supports FDA’s authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear agents, including emerging
Drugs
CDER researchers say more study is needed to assess the association between frailty, as measured by the Patient-Reported Frailty Phenotype they developed, and clinical outcomes in multiple myeloma. Further work also is needed to compare this phenotype with other frailty measures, they say in an agency online post “Given
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is asking the Supreme Court to hear an appeal from the 11th Circuit Court of Appeals that involves the potential for state tort-law liability if drug companies fail to unilaterally change language in the Highlights section of prescription medicine labeling. In its
Devices
FDA says it is developing a general policy for the use of enforcement discretion for unauthorized tests in public health emergencies, which will be based on “lessons learned” from both the Covid-19 and monkeypox public health emergencies. The agency acknowledged the effort during a recent Government Accountability Office (GAO)
Drugs
FDA has issued a complete response letter to Sweden’s Xspray Pharma for its NDA for Dasynoc (dasatinib amorphous) to treat chronic myeloid leukemia, its first product to be reviewed by the agency. The company says FDA requested additional information regarding additional information to doctors and users related to the
Biologics
Takeda says it has withdrawn a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on “aspects of data collection, which cannot be addressed within the current BLA review cycle.” The vaccine’s future plan in the U.S. will be further evaluated, it says, adding
Devices
FDA has given 510(k) clearance to an Avatar Medical virtual reality surgical planning device. The company says it helps surgeons better prepare their procedures by using virtual reality representations of their patients. The patient avatars are generated instantly from CT scans or MRI images with an underlying proprietary technology,
Drugs
FDA says Cipla US has recalled six batches of albuterol sulfate inhalation aerosol, 90 mcg (200 metered inhalation) due to a container defect that could result in a failure to deliver the recommended dose. An agency statement says the six batches were manufactured in 11/2021. The statement says Cipla
Drugs
FDA has lifted its 4/4/22 partial clinical hold on the Curis TakeAim Leukemia Phase 1/2 study of emavusertib in patients with B-cell malignancies. Under the hold, the agency requested additional safety, efficacy, and other data relating to the drug, including data on rhabdomyolysis and the company’
Drugs
Three Hogan Lovells attorneys say the FDA finalization of a 2018 draft guidance with recommendations on how companies can best present quantitative efficacy and risk information in direct-to-consumer (DTC) promotional materials may signal that the CDER Office of Prescription Drug Promotion (OPDP) “may be preparing to return to
Devices
FDA says it has determined that a cybersecurity vulnerability affecting the universal copy service software in several Illumina DNA sequencing instruments is considered a Class 2 recall, a situation in which using the device may cause serious adverse health consequences. An agency statement says the vulnerability was first announced in
Drugs
Ipsen says it plans to meet with FDA officials and then submit a regulatory application for its elafibranor to treat patients with primary biliary cholangitis. Ipsen and Genfit said elafibranor met its primary endpoint in the Phase 3 ELATIVE trial with a statistically significant higher percentage of patients achieving a