FDA Policy/General
FDA’s fiscal year 2023 spending bill was signed into law 12/29/2022 as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) that gives the agency a 6.5% boost ($226 million) above FY 2022 spending levels. In total, the measure provides FDA’s
Drugs
The CDER Office of New Drugs (OND) has granted Ardelyx’ appeal of a complete response letter for its NDA for kidney disease drug Xphozah (tenapanor). A company statement says that in granting the appeal, OND directed the Division of Cardiology and Nephrology to work with Ardelyx to develop an appropriate
Devices
The Department of Justice says Advanced Bionics, a Valencia, CA, manufacturer of cochlear implant system devices, will pay more than $12 million to resolve a whistleblower’s allegations that it misled federal healthcare programs about the radio-frequency (RF) emissions generated by some of its processors. A department statement says
FDA Policy/General
FDA has issued a draft update to guidance for industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is intended to help stakeholders assess antimicrobial resistance (AMR) risks in people due to use of medically
Devices
FDA has cleared a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FFS is an integrated cage and screw system that is implanted bilaterally in
Drugs
FDA has approved an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer. The drug was approved 11/2021 for identifying ovarian cancer lesions. The new indication was evaluated in a randomized, multicenter, open-
Biologics
FDA has approved a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector‑based gene therapy indicated for treating adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Approval
Biologics
FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider “whether and how the composition for primary doses of the currently available Covid-19 vaccines should be modified and how and whether the composition and schedule for booster doses
FDA Policy/General
The House 12/14 passed S 3905 Preventing Organizational Conflicts of Interest in Federal Acquisition Act that aims to curb government contractors from having conflicted relationships with agencies like FDA and private-sector companies, like pharmaceutical or device companies. The Senate passed the bill in the summer and it now
Drugs
Dr. Reddy’s subsidiary Aurigene Oncology says it is stopping the development of its psoriasis investigational drug after reporting results of INDUS-3, a Phase 2b double blind placebo-controlled study conducted in the U.S. “The magnitude of efficacy improvement with AUR101 (versus placebo) in psoriasis is not what
Drugs
FDA has released a draft guidance entitled “Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.” The document is intended to provide current agency recommendations regarding the overall development program for a new investigational drug or drugs to be used in combination with approved drugs, or as a new treatment regimen that
Drugs
FDA has published a draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, to define the types of behaviors (actions, inactions, or circumstances) that FDA considers to be delaying, denying, or limiting an inspection, or refusing to permit entry or inspection for the purposes
Biologics
Three Ropes & Gray attorneys say a potential split between the 9th and 11th Circuit Courts of Appeals over stem cell therapy regulation could “fundamentally alter FDA’s ability to regulate stem cell therapies.” Writing in an online Alert, the attorneys outline the two cases that are setting up the
Drugs
FDA has published a revised guidance, Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe, to assist ANDA applicants in responding to complete response letters. The document revises a 7/2022 guidance by incorporating performance goals outlined in the GDUFA 3 commitment letter. The agency says
Drugs
FDA has approved updated labeling for Genentech’s Xeloda (capecitabine) tablets. An agency announcement says the revised labeling was approved under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
Drugs
FDA has extended by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssen’s Zytiga (abiraterone) and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer. The companies say the review extension is needed for the full
Drugs
Responding to an FDA draft guidance on characterizing, collecting, and reporting immune-mediated adverse reactions in cancer immunotherapeutic clinical trials, Bristol-Myers Squibb says it is expected that as new traditions and times of therapy are developed, a better understanding within the healthcare community and the sponsor’s database/experience
FDA Policy/General
A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from potential political interference, such as converting FDA into an independent agency like the Federal Reserve. GAO said it conducted the review of political interference during the Covid-19 emergency based on allegations it had
Drugs
There are now four states seeking federal approval for plans to import some prescription drugs from Canada. Kaiser Health News (KHN) reports that Colorado filed its proposal on 12/5, joining Florida, New Hampshire, and New Mexico. KHN says President Joe Biden has endorsed the approach but the administration has
Drugs
Responding to an FDA discussion paper on distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that “globally harmonized approaches towards innovative manufacturing regulation will help ensure these advances provide their intended benefits.” The PhRMA comment letter encourages
Devices
AdvaMed says it supports FDA efforts through a draft guidance to update the breakthrough devices program. The association’s comment letter says it strongly supports FDA efforts to clarify how the program may apply to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly
Devices
Attorneys Gail Javitt and Jeffrey Gibbs (Hyman, Phelps & McNamara) say the “grandfathering” provision in the proposed VALID Act to regulate laboratory-developed tests (LDTs) could adversely affect in-home specimen collection used in telehealth applications. Writing in their firm’s FDA Law Blog, the two say it does not