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Products (HCT/Ps): Minimal Manipulation and Homologous Use.” 11/17/2017 Expedited Programs for Regenerative Medicines Draft Guidance Federal Register notice: FDA makes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
Drugs
FDA’s Antimicrobial Drugs Advisory Committee has voted 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals’ ciprofloxacin dry powder for inhalation for use in treating non-cystic fibrosis bronchiectasis. Panel members said they had concerns about inconsistent data, drug resistance and having met only one of four primary
Drugs
Pfizer subsidiary Greenstone has recalled multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential to be super potent or sub potent. They were distributed nationwide to wholesalers/retailers from 11/2016 through 6/2017. “The use of this product in patients with uncontrolled diarrhea
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Puerto Rico this summer. Presumably, the agency is reacting to concerns raised late last week by the American Hospital Association, which urged the agency to intervene and “expedite
Devices
FDA has issued a guidance, Unique Device Identification: Direct Marking of Devices, to assist industry, and particularly labelers, to understand agency requirements for direct marking of medical devices for unique device identification (UDI). The question-and-answer document defines some terms used in agency regulations on the UDI direct marking
Drugs
By unanimous consent, the Senate agreed 11/16 to a House bill leaving to FDA decisions for battlefield drugs and medical devices. The House adopted HR 4374, introduced by Rep. Greg Walden (R-OR) the day before the Senate vote. The bill is intended to correct a provision adopted by
Drugs
FDA has approved Genentech’s Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (Stage II bulky, III or IV). Approval is based on results from the Phase 3 GALLIUM study, which showed superior progression-free survival
FDA Policy/General
Federal Register notice: FDA has announced a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members will discuss a Lipocine Inc. NDA for oral testosterone undecanoate capsules, seeking an indication for testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone:
FDA Policy/General
Federal Register notice: FDA has announced that an initial decision of the administrative law judge (ALJ) is now the final agency decision on refusing approval of a supplemental NDA for Mepergan Fortis capsules (meperidine HCl, promethazine HCl). The ALJ found that the product had not been shown to be supported
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Best Practices for Convening a GRAS Panel.” The document covers agency recommendations for convening a generally recognized as safe (GRAS) panel of experts to independently evaluate whether available scientific data, information, and methods establish that the substance is safe
Drugs
The Government Accountability Office (GAO) says FDA implemented requirements for reviewing applications for sunscreen active ingredients within time frames set by the 2014 Sunscreen Innovation Act. The act contained a provision for GAO to examine FDA’s implementation. As an example of meeting time frames, GAO says FDA issued an
Drugs
FDA has approved Genentech’s Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. An FDA announcement says that Hemlibra is a first-in-class therapy that works by bridging other
Drugs
FDA has approved Pfizer’s Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. “This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with
Drugs
FDA has accepted an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add-on therapy with its Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. The agency has set a 6/30/2018 user fee review target action date for the submission. “If approved, administration of