FDA Policy/General
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Drugs
FDA’s authority to obtain equitable remedies in injunction suits may be in jeopardy in light of federal court questions in a Federal Trade Commission (FTC) case against Shire. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the Shire
Devices
An FDA analysis required by the 21st Century Cures Act says that there generally are more benefits than risk to patient safety and health from the use of non-medical device software digital health products. The Cures Act excludes certain software functions from the statutory definition of a medical device
Drugs
FDA says it is withdrawing its 2013 proposed rule on supplemental applications proposing labeling changes for approved drugs and biological products that would have allowed generic drug makers to independently update and distribute new safety information in drug labels. A statement from FDA commissioner Scott Gottlieb and CDER director Janet
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Novimmune for its approved rare pediatric disease product application for Gamifant (emapalumab-lzsg) injection, indicated for treating adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional
FDA Policy/General
Federal Register notice: FDA has determined that Akorn’s IC–Green (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs for indocyanine green for injection,
Devices
FDA says it is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to changes made in the FDA Safety and Innovation Act (FDASIA). A Federal Register notice says the rule also makes additional changes, unrelated to FDASIA, to update other affected
Devices
FDA has cleared a Tangible Science 510(k) for its daily disposable silicone hydrogel contact lens coated with a modified formula of Tangible Hydra-PEG, which is intended to improve lens wettability and deposit resistance. The lens utilizes a “variation designed to enhance the surface of daily wear lenses,” the
Drugs
FDA has granted Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the company’s novel small molecule topoisomerase 1inhibitor for treating Ewing sarcoma, a rare pediatric cancer. LMP-400 has completed multiple Phase 1 human clinical trials as a single agent in advanced stage cancer patients, with the
FDA Policy/General
FDA says it has worked with Pfizer to help alleviate a shortage of certain injectable opioids available to treat pain in animals. An agency statement says it is facilitating the availability of a limited amount of product labeled for human use. The notice says that the Center for Veterinary Medicine
Drugs
The Leukemia & Lymphoma Society says it supports an FDA draft guidance on regulatory considerations for use of minimal residual disease (MRD) in development of drug and biologic products to treat hematologic malignancies. “We agree with FDA’s assertion that MRD as a general measure of tumor burden has multiple
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain
FDA Policy/General
Federal Register notice: FDA has announced the availability of a final guidance entitled “Interpretation of the ‘Deemed To Be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009.” This document describes FDA’s interpretation of the statutory provision under which an application for a biological product
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance entitled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers.” The document is intended to provide answers to common questions about FDA’s interpretation of the statutory provision under which an application for
Drugs
FDA has issued a guidance, Data Integrity and Compliance with Drug CGMP Questions and Answers, to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The document says the term CGMP basically refers to CGMPs for drugs, including biologics. “This guidance provides the agency’s
Devices
FDA has issued a guidance, User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications, to identify (1) the types of PMAs and BLAs subject to device user fees; (2) exceptions to user fees; and (3) actions that may result in refunds of user fees that have
Drugs
FDA is warning consumers that two e-liquids sold by HelloCig Electronic Technology Co. contain undeclared prescription drug active ingredients. An agency alert says that the “E-Cialis HelloCig E-liquid” contains sildenafil and tadalafil, while the “E-Rimonabant HelloCig E-liquid” contains sildenafil. FDA says the undeclared ingredients may
Drugs
Three Fried Frank attorneys say that if False Claims Act (FCA) cases that look at the materiality of the claims being made, the government should be required to provide full discovery to the parties. However, they write in a Washington Legal Foundation Legal Opinion Letter, in some recent cases, the
Drugs
TherapeuticsMD is asking FDA not to receive or approve any ANDA that references Imvexxy (estradiol vaginal inserts) unless the ANDA sponsor provides data consistent with the bioequivalence requirements suggested in the TherapeuticsMD petition. The company also asks the agency to issue a product-specific bioequivalence guidance for Imvexxy. It notes
Drugs
FDA has accepted an Intra-Cellular Therapies NDA for lumateperone, an investigational agent for treating schizophrenia. The submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone, which received an FDA fast track designation 11/2017. The agency has set a user
Drugs
FDA has issued Mallinckrodt subsidiary SpecGx a complete response letter on its NDA for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company says the letter provided