Drugs
FDA has released a final guidance entitled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.” Under the guidance, the agency recommends that generic oral tablets and capsules intended to be swallowed intact should be of a similar size to the corresponding reference-listed drug (RLD). The agency
Drugs
FDA has approved a Taiho Oncology NDA for Lytgobi (futibatinib) for treating adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic bile duct cancer (cholangiocarcinoma) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements, which is determined using next-generation sequencing. Approval was based on
Drugs
FDA has issued India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4. The company says it does not believe that the Letter will have an impact on product supplies. “We are committed to addressing the concerns raised by the U.
Drugs
FDA has expanded CDER’s NextGen Portal to enable certain electronic over-the-counter (OTC) monograph submissions under section 505G of the Federal Food, Drug, and Cosmetic Act. “Requests for formal meetings between FDA and sponsors and requestors of OTC monograph drugs and related meeting correspondence (e.g., meeting packages)
Drugs
FDA has added important information to the emergency authorization of AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals about the increased risk for developing Covid-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. The agency says
Drugs
FDA has posted a draft guidance entitled “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA” that introduces an enhancement under the reauthorized generic drug user fee program that became effective 10/1. The document is intended for holders of Type 2 active pharmaceutical ingredient (API)
Biologics
FDA has awarded the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) a $1.3 million grant to support biosimilars research and a study focused on increasing the efficiency of biosimilar drug development and review. The study is entitled “Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by
Devices
FDA has cleared a GE Healthcare 510(k) for its AIR Recon DL for 3D and Propeller imaging sequences for use during magnetic resonance imaging (MRI) clinical procedures, claimed to enable better image quality and shorter scan times. The device's image reconstruction technology for MRI is now expanded
Drugs
BioMarin has resubmitted its BLA for gene therapy valoctocogene roxaparvovec for adults with severe hemophilia A. The resubmission includes the company’s response to a 2020 complete response letter and subsequent agency feedback, including two-year outcomes data from the global GENEr8-1 Phase 3 study and supportive data from
Devices
LivaNova (TandemLife) has recalled its LifeSPARC Controller, part of the LifeSPARC pump system, due to a software malfunction. The controller’s monitoring feature may erroneously detect “frozen or unresponsive software and trigger the device to enter critical failure mode — clearing the controller screen and issuing an alarm that cannot be
FDA Policy/General
A continuing resolution (see earlier story), which includes the five-year reauthorization of FDA’s user fee programs, is signed into law by President Biden on 9/30. Earlier in the day, the resolution was passed by a House vote of 230-201. The previous day, the Senate passed it
Drugs
More than one-third of accelerated approval drugs (104 of 278 between 1992 and 2021) are past their confirmatory trials’ original planned completion dates, including four that are more than five years past those dates, an HHS Inspector General (IG) data snapshot says. The snapshot is part on an ongoing
Devices
A new final guidance on Clinical Decision Support (CDS) Software appears to be “more expansive in scope” than an earlier draft version, and many software products previously not regulated by FDA may now be subject to agency oversight, according to a legal analysis by attorneys at the law firm DLA
Drugs
East Windsor, NJ-based Eugia U.S. (formerly AuroMedics Pharma) has recalled one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a product complaint about the presence of a dark red, brown and black particulate inside a vial. “The administration of an intravenous
FDA Policy/General
FDA has approved Bimeda Animal Health’s SpectoGard (spectinomycin sulfate), the first generic copy of Pharmacia Animal Health’s Adspec for treating bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. An FDA news release warns that allergic reactions may occur in previously sensitized individuals. “Repeated or
Drugs
FDA says manufacturing-related deficiencies contribute significantly to a low rate of ANDA approvals for modified-release tablet products during the first review cycle. Writing in the 9/28 issue of the journal AAPS PharmSciTech, CDER researchers said only 12% of such products were approved first cycle between fiscal years
Devices
FDA has published a guidance, Display Devices for Diagnostic Radiology, to assist industry in preparing 510(k) submissions for display devices intended for use in diagnostic radiology. The document says while it is intended to apply to current technologies, FDA may request new or alternative methods to fully evaluate the
Devices
FDA has published a guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, with the agency’s current thinking on the listed devices to provide clarity and predictability for their manufacturers. The document notes that FDA down-classified medical device data systems (MDDS) from Class
FDA Policy/General
Federal Register notice: FDA has amended its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during January, February, and March. Additionally, it is making available summaries of the basis of approval and environmental review documents, where applicable. To view
FDA Policy/General
Federal Register notice: FDA has announced a 10/26 public meeting entitled “Animal Generic Drug User Fee Act” that will discuss the proposed recommendations for the reauthorization of the Animal Generic Drug User Fee Act for fiscal years 2024 through 2028. Electronic or written comments can be submitted by 11/
Drugs
The National Institutes of Health (NIH) says the Accelerating Medicines Partnership (AMP) Heart Failure program, which includes FDA among its members, has launched. The program is focused on heart failure with preserved ejection fraction (HFpEF) and is investigating the multiple factors that lead to HFpEF, seeking to determine the phenotypes
Biologics
Sarepta Therapeutics has submitted a BLA seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) to treat ambulant patients with Duchenne muscular dystrophy. SRP-9001 is a gene therapy being developed in partnership with Roche. The submission relies on the expression of SRP-9001 dystrophin protein, “an internally shortened and functional