FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its guidance on “Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program OMB Control Number 0910-0569.” The voluntary third-party inspection program is applicable to manufacturers of Class 2 or
Drugs
FDA has approved a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Current HIV combination products include three or more drugs included in standard HIV treatment. “Limiting the number of drugs in any
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it shares FDA’s efforts to help advance the benefit-risk related initiatives under PDUFA 5, but believes that additional guidance and clarity are needed on implementation of the benefit-risk framework to help ensure timely patient access to innovative biopharmaceuticals that
FDA Policy/General
The House Commerce Subcommittee on Health has announced an 11/30 hearing on “Implementing the 21st Century Cures Act: An Update from FDA and NIH.” The hearing intends to examine the law’s implementation as its one-year anniversary approaches. The 21st Century Cures Act is intended to accelerate the
Drugs
Responding to an FDA request for comment on ensuring a balance between innovation and access in the Waxman-Hatch Act, the Biotechnology Innovation Organization (BIO) says there is an appropriate and necessary role for state laws in outlining the circumstances, authorities, and communication protocols for product substitution. “The designation of
Drugs
A 7/31-8/4 FDA inspection at Hubei Danjiangkou Danao Pharmaceutical Co., Hubei Province, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/6 Warning Letter. Specific deviations cited were: * failing to demonstrate that the firm’s manufacturing process can
Drugs
Genentech has filed suit in Delaware federal court claiming that Pfizer will infringe or induce infringement of 40 Genentech patents on its breast cancer drug Herceptin (trastuzumab) by proceeding with its aBLA for a biosimilar to Herceptin. Genentech says Pfizer notified it 11/17 under the Biologics Price Competition and
FDA Policy/General
Federal Register notice: FDA has extended its comment period provided in a 7/31 Federal Register notice entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments.” That notice announced the public workshop and requested comments by 11/28; FDA is extending the public workshop’s comment period by 30 days
FDA Policy/General
Federal Register notice: FDA is seeking comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements for over-the-counter denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The document provides tissue establishments and health care professionals with FDA’s current thinking on the scope of an exception outlined
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The document provides the agency’s current thinking on the regulatory criteria
Devices
FDA has approved a Medtronic PMA for its Azure pacemakers with BlueSync technology. The devices are available in both single chamber and dual chamber models, and offer improved longevity, estimated at 13.7 years, according to the company. The new pacemakers also allow patients to have magnetic resonance imaging scans
Drugs
FDA has granted PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with basal cell carcinoma Nevus syndrome, a rare genetic disease also known as Gorlin Syndrome. The designations are based on data from a Phase 2 trial assessing the safety and efficacy of topical
Drugs
A new report from the White House’s Council of Economic Advisers estimates that the ongoing opioid crisis cost the U.S. $504 billion (2.8% of gross domestic product) in 2015 and led to over 33,000 American overdose deaths. Survey data indicate that 2.4 million Americans have
FDA Policy/General
Federal Register notice: FDA has acknowledged that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s biologics license application (BLA). The notice indicates that Janssen Biotech has filed suit against Celltrion Healthcare (17–CV–11008 in
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Direct Marking of Devices.” This document is intended to clarify when direct marking of devices with a unique device identifier is required, and to assist in understanding direct marking requirements. To view the notice, click here.
Drugs
FDA has approved a Kaléo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds who are at risk for or have a history of serious allergic reactions. The auto
FDA Policy/General
Guide on Cell/Tissue-Based Product Regulatory Considerations Federal Register notice: FDA releases a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” 11/17/2017 Expedited Programs for Regenerative Medicines Draft Guidance Federal Register notice: FDA makes
FDA Policy/General
FDA has released a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” The document provides the agency’s criterion for determining minimal manipulation and homologous use. It also outlines that over the next 36 months, FDA intends
Drugs
Congresswoman Rosa DeLauro (D-CT) has reintroduced a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer (DTC) drug advertising. The measure was referred to the House Committee on Energy and Commerce which will consider it before sending it to the House
Drugs
Federal Register notice: FDA is correcting an 11/3 Federal Register notice entitled “Controlled Correspondence Related to Generic Drug Development.” The document was published with an incorrect docket number. The correct Docket No. is FDA-2014-D-1167. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA makes available a draft guidance on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The draft describes the expedited programs available to sponsors of these therapies for serious or life-threatening diseases or conditions; how CBER will work with sponsors and encourage flexibility in clinical