Drugs
In a bid to stimulate the domestic pharmaceutical industry and secure the U.S.’s drug supply chains, Congresswoman Claudia Tenney (R-NY) has introduced the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. The bill proposes various tax incentives aimed at enticing pharmaceutical companies
Drugs
FDA has republished a 3/2021 guidance, Covid-19 Container Closure System and Component Changes: Glass Vials and Stoppers, with a note that the document is intended to remain in effect until 8/7/2024 unless superseded by a revised final guidance before that date. The guidance collated recommendations for
Devices
Johnson & Johnson says it intends to submit its Ottava robotic surgical system for an IDE in the second half of 2024 to open clinical trials. The company says Ottava is designed to create space in the operating room, simplify complex workflows, enable flexibility for clinical approaches, and deliver the
Drugs
Three CDER researchers say 39% of the 240 requests for a breakthrough therapy designation (BTD) submitted from 1/1/2017 through 12/31/2019 were granted by the agency, while 61% were denied. Writing in the open-source Therapeutic Innovation & Regulatory Science, the researchers say approval of requests was
Devices
FDA has cleared a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes. “Prefilled syringes are proven to provide a significant improvement in ease of use for all patients, and in administering higher doses of immunoglobulin, including for PIDD [primary immunodeficiency disorder] and
Drugs
FDA has released the 20-page form FDA-483 issued following a 10/12-10/20 inspection at Kilitch Healthcare India, a sterile drug manufacturing facility in Navi, Mumbai, Maharashtra, India. The 14 inspection observations were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of Phibro Animal Health’s NADAs for carbadox in medicated swine feed. This action is based on CVM’s determination that there is no approved regulatory method to detect carcinogenic residues in the edible tissues of treated swine. Carbadox is indicated
Biologics
The International Society for Cell & Gene Therapy (ISCT) says an FDA draft guidance on manufacturing changes and comparability for human cellular and gene therapy products “could benefit from more detailed information as it covers a very broad range of therapeutic products.” The ISCT comment letter says the analytical approach
Drugs
In a major move aimed at curbing rising drug prices and promoting fair competition, the Federal Trade Commission (FTC) has challenged the legitimacy of more than 100 patents listed in FDA’s Orange Book (also known as “Approved Drug Products with Therapeutic Equivalence Evaluations”). The disputed patents are held by
Drugs
Attorney Douglas Farquhar and senior regulatory expert Richard Lewis (Hyman, Phelps & McNamara) say the fact that FDA has conducted fewer than 10 remote interactive evaluations (RIEs) at drug manufacturing sites since 4/2021 is a “missed opportunity,” given that on-site inspections dropped off dramatically three years ago due
Drugs
Law firm Sidley has petitioned FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity (ODE) to Pyros Pharmaceuticals’ vigabatrin oral solution (PYR-003), indicated for infantile spasms, unless Pyros can demonstrate that its version of vigabatrin is “clinically superior” to all previously approved versions.
Drugs
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three indications — macular edema following retinal vein occlusion, wet age-related macular degeneration and non-proliferative diabetic retinopathy (NPDR). Kodiak says the regulatory pathway was recently discussed with FDA
Drugs
FDA has granted Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast cancer with leptomeningeal metastases (LM). The therapy is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. FDA previously granted rhenium obisbemeda a fast track designation for
Drugs
FDA has posted a final guidance entitled “Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory.” The document provides technical specifications for submitting clinical outcome assessment (COA) data that use “Item Response Theory (IRT)” under CDER’s Patient-Focused Drug Development program. It explains that
Devices
FDA has reissued a guidance document entitled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices” that includes minor updates to align with the recent Consolidated Appropriations Act of 2023. The document describes the information that the agency will provide to a
Devices
FDA has cleared a Neurovalens 510(k) for its Modius Sleep device for treating chronic insomnia. The device is designed to improve insomnia by delivering a small electrical pulse to the head 30 minutes before bed, the company says, adding that users can do other activities (watching TV or reading)
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Foradil (formoterol fumarate) inhalation powder (.012 mg) was not withdrawn due to safety or effectiveness concerns. The determination will allow the agency to approve ANDAs referencing the product if all other legal and regulatory requirements are met. Foradil is indicated for treating
Devices
CDRH says it has recognized and supports industry’s use of a key consensus standard to support device sponsors in their cybersecurity efforts. The standard in entitled “ANSI/AAMI SW96:2023 Standard for medical device security —- Security risk management for device manufacturers.” The Center says it “aligns with existing international
Devices
Teleflex and subsidiary Arrow International are recalling their Pressure Injectable Catheter Kits due to mislabeling about the presence of chlorhexidine in the products. The product code and product name are incorrectly listed as non-coated on the lids of the affected devices, a recall notice says. However, the banner card
Drugs
FDA has approved a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for treating adults with all grades of erosive esophagitis (also known as erosive gastroesophageal reflux disease (GERD)) and relief of heartburn associated with erosive GERD. Approval is based on
Drugs
FDA has published a final guidance entitled “Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.” The document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology. It defines a PRO as a
FDA Policy/General
Federal Register notice: FDA has identified certain Class 2 clinical electronic thermometers that, when this action is finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is requesting public comment on this action during a 60-day comment period and will consider whether any modifications should