Drugs
Apotex is asking the Federal Circuit Court of Appeals to review a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. A Big Molecule Watch blog post says that Apotex is
Drugs
Acting at FDA’s request, U.S. marshals seized nearly 90,000 bottles of Dordoniz Natural Products’ RelaKzpro that was labeled as containing kratom. An FDA news release says the seized product was worth more than $400,000. The release says that a 2/2014 FDA import alert allows U.
Drugs
FDA warning and untitled letters to drug makers on their advertising and promotion violations dropped to an all-time low last year. CDER’s Office of Prescription Drug Promotion’s (OPDP) issued nine such letters in 2015, one less than it issued in 2014. In contrast, OPDP had issued on
Drugs
FDA and Dallas-based drug compounder Downing Labs have agreed to a consent decree that bars the firm from making or distributing drug products until it is in GMP compliance and meets other terms of the agreement. The decree also calls for the firm to hire a GMP expert who
Drugs
PDUFA 6 reauthorization negotiators in the regulatory decision tools subgroup discussed innovative clinical trial design and model-informed drug development (MIDD) at their 11/18/15 meeting. Meeting minutes say that agency and industry subgroups members continued discussion of proposed enhancements intended to advance simulation approaches that can support innovation
Devices
Rep. Mike Fitzpatrick (R-PA), who has been championing relief measures for patients injured by power morcellators and Bayer’s Essure permanent birth control device, has introduced an amendment that would overturn the U.S. Supreme Court’s landmark Riegel v. Medtronic decision and allow patients harmed by a PMA
Drugs
FDA says Hospira has recalled one lot of magnesium sulfate in water for injection with an expiration date of 11/1/16 due to a confirmed customer report of an incorrect barcode on the primary bag labeling. An FDA publication of a company news release says that the product has
Devices
CDRH has published lists of guidance documents that it intends to publish in FY 2016 and previously-issued final guidances for which it wants to receive external feedback on whether they should be revised or withdrawn. There are two lists of guidances the Center wants to issue — an “A-list”
Drugs
A group of healthcare stakeholders is urging the Senate Special Committee on Aging to take up legislation to curb the increasing use of restricted access programs by brand drug makers to block generic entry into the market. In a recent letter to committee leaders, the stakeholders complain that some brand
Devices
NBC News says confidential C.R. Bard records it obtained show that the company replaced a blood clot filter associated with 27 deaths and hundreds of problems with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market. The news
Drugs
CDER director Janet Woodcock has announced a change in workflow processes within the Center’s Office of Compliance effective 1/1 to prevent potential conflict of interest issues. Office of Compliance director Cynthia Schnedar must recuse herself from working on substantive issues relating to compliance actions and policy, according to
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cadila Healthcare Ltd. Ahmedabad, India (12/23/15). Inspected two pharmaceutical manufacturing facilities in 2014: Sarkhej-Bavla Road, N.H. No. 8A, Moraiya, Tal. Sanand, Ahmedabad, Ahmedabad City 8/
Drugs
The new year should see more changes in FDA’s enforcement of off-label promotion, according to a Latham & Watkins client alert that examines the recent FDA and Pacira Pharmaceuticals settlement (see earlier story). “FDA’s concessions regarding the lawfulness of Pacira’s promotion of specific uses within a
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the reporting requirements contained in the draft guidance for industry and review staff entitled Target Product Profile — A Strategic Development Process Tool. Comments should be submitted by 3/7. The draft guidance is intended to provide sponsors and FDA review staff
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or notice of completion of a product development protocol for surgical mesh for transvaginal pelvic organ prolapse repair. To view this final order, click here.
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse repair from Class 2 to Class 3, based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this
Drugs
FDA has posted a Warning Letter (see earlier story) to India’s Cadila Healthcare that cites numerous GMP deviations following two 2014 inspections its Moraiya formulation facility and Ahmedabad active pharmaceutical ingredient (API) facility. Company officials have reportedly initiated steps to transfer some products to other manufacturing sites. At the
Devices
An 8/24-8/27/15 FDA inspection at the Sorin Group manufacturing facility in Munchen, Germany, identified Quality System Regulation and other violations in the firm’s manufacturing of Stockert Heater Cooler 3T thermal regulator devices. A 12/29/13 Warning Letter says that specific violations noted on an
FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee 1/12 will vote on Robert Califf’s nomination to become the next FDA commissioner. While his earlier nomination hearing was relatively supportive, Califf was grilled by committee member and presidential candidate Bernie Sanders (I-VT), who is concerned about his previous
Devices
FDA has issued a medical device safety communication urging healthcare providers in Puerto Rico and staff at healthcare facilities or hospitals in Puerto Rico not to use Customed convenience packs and trays for any surgical procedures. The notice says that the integrity, safety and efficacy of the products can’t
Devices
Lanx, Inc., a spinal fixation device maker, won a product liability case in Mississippi last month by relying upon, among other defense arguments, the Buckman U.S. Supreme Court decision on federal preemption. In Estes v. Lanx, Inc., plaintiff Rocky Estes underwent spinal fusion surgery in 2011 that used the
Drugs
Some seven academic and government researchers in the U.S. say that despite a growing movement to encourage reproducibility and transparency practices in the scientific community, including public access to raw data and protocols, the conduct of replication studies, systematic integration of evidence in systematic reviews, and documentation of funding