Drugs
FDA has issued a drug safety alert to warn that taking higher than recommended doses of the common over-the-counter and prescription diarrhea medicine loperamide (Imodium) can cause serious heart problems that can lead to death. “The risk of these serious heart problems, including abnormal heart rhythms, may also
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Forms FDA 3486 and 3486A. Comments should be submitted by 8/8. To
FDA Policy/General
The Mid-Year Update for the 2016 HHS Inspection General (OIG) work plan includes two new FDA studies — one to review prescription drug user fees and one to review networked medical device cybersecurity during the device approval process. Both study reports are expected to be issued in FY 2017. The
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. 86 Harriet Ave. Corp. dba General Devices Ridgefield, NJ (6/1). Inspected 6/2/15-6/11/15. QSR deviations, adulterated: The firm failed to adequately establish procedures for
Devices
FDA has sent Zimmer Biomet a Warning Letter related to GMP deficiencies observed during a Quality System inspection in January at the company’s Montreal, Canada manufacturing facility. The company says the facility is the principal location of its wholly-owned subsidiary, ORTHOsoft, Inc. At the conclusion of the inspection,
Devices
FDA has cleared a Cereve de novo petition to allow marketing of its Sleep System, a prescription device that the company says is intended to reduce latency to Stage 1 and Stage 2 sleep for people with insomnia. The device was developed based on research at the University of Pittsburgh
FDA Policy/General
Federal Register Notice: FDA is seeking comments on the proposed information collection requirements relating to FDA regulations for human tissue intended for transplantation. Comments should be submitted by 8/5. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that five drug products (Apresoline, Proventil, K-Dur, Mycolog II, and Kenalog) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for a 4/4 Federal Register notice on a draft guidance entitled Labeling for Biosimilar Products; Draft Guidance for Industry. Comments should be submitted by 8/2. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is correcting a 10/13/15 Federal Register notice, which announced the withdrawal of approval of 67 NDAs and 128 ANDAs from multiple applicants, effective 11/12/15. The document indicated that FDA was withdrawing approval of two Merck NDAs: NDA 016096, Mintezol (thiabendazole) tablets, and
Drugs
FDA has issued Adamis Pharmaceuticals a second Complete Response Letter (CRL) on an NDA for epinephrine injection USP pre-filled single dose syringe product for the emergency treatment of acute anaphylaxis. The NDA was resubmitted earlier this year to address issues raised by a CRL issued 3/2015. That letter
Drugs
The DC Circuit Court of Appeals has upheld a lower court ruling that found FDA was correct in approving a Sandoz ANDA for a generic copy of Spectrum Pharmaceuticals’ Fusilev (levoleucovorin) despite orphan drug exclusivity on a use for which Sandoz had not sought approval. Pursuant to FDA regulations, Sandoz’
Drugs
FDA has issued a drug safety alert to warn consumers about the risk of serious bleeding when using over-the-counter, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. “These widely used products already contain warnings about this bleeding risk on their labels; however,
Drugs
FDA has approved an Allergan NDA for Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, indicated for treating hypertension to lower blood pressure. The company says the product is the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the U.S. Approval
Drugs
Joint comments from the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council have raised concern about a proposed biosimilarity statement recommended in a draft guidance on Labeling for Biosimilar Products because they say it is not only unnecessary but also may be confusing to patients and healthcare providers. The recommendations
Drugs
FDA has denied a Public Citizen petition that urged the agency to remove from the market Cypress Bioscience/Forest Laboratories’ Savella (milnacipran). The 1/20/2010 citizen petition said the drug, approved 1/14/09 for managing fibromyalgia in adults, has highly questionable clinical efficacy and has been found in
FDA Policy/General
Novartis Pharmaceuticals and Eisai will collaborate on commercial and certain medical affairs activities in the U.S. to co-promote Lenvima (lenvatinib) capsules in combination with Novartis’ Afinitor (everolimus) for treating patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. The two companies say that they will
FDA Policy/General
BIOLOGICS OMB Clearance Sought on Biologic Naming Guidance Federal Register Notice: FDA has submitted to OMB for clearance a proposed collection of information contained in the agency’s guidance on “applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name
Devices
FDA has cleared a First Ray 510(k) for the SpeedButton System for attaching soft tissue to bone. “Reattachment of ligaments and capsular tissue to bone using conventional suture anchors is problematic in the presence of decortication at the attachment site,” the company says. “Quality of the fixation may be
Drugs
FDA has granted Escend Pharmaceuticals an orphan drug designation for ES-3000 and its use for treating chronic myeloid leukemia (CML). ES-3000 is an orally bioavailable small molecule which ablates leukemic stem cells by reducing β-catenin expression through a novel mechanism of action, according to the company. The
FDA Policy/General
Federal Register Notice: FDA has submitted to the Office of Management and Budget a proposed information collection extension regarding reporting associated with New Animal Drug Applications. The information collected in the applications is used to review the data, labeling, and manufacturing controls and procedures to evaluate the safety and effectiveness
FDA Policy/General
Federal Register Notice: FDA has published a guidance on “Charging for Investigational Drugs Under an IND — Questions and Answers.” The document provides information on the implementation of the agency’s regulation on charging for investigational drugs for the purpose of either clinical trials or expanded access for treatment use. To