FDA Policy/General
The U.S. District Court for the Western District of Louisiana has entered a consent decree against dietary supplement maker Pick and Pay Inc./Cili Mineral and its owner, Anton S. Botha, ordering the business to immediately cease operations until it comes into compliance with federal laws. A Justice Department
FDA Policy/General
DEVICES FDA has cleared an Access Scientific 510(k) for its new 3 French, 6cm Powerwand, an extended-dwell intravenous (IV) catheter designed for forearm and upper-arm (midline) placement to eliminate the repetitive needlesticks experienced by many hospitalized patients. The device is made of proprietary Chronoflex C, and is
FDA Policy/General
Draft Guide on Drug Starting Materials Federal Register Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting
FDA Policy/General
Federal Register Notice: FDA has issued an order to permanently debar Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under federal law
FDA Policy/General
The Government Accountability Office (GAO) continues to monitor FDA staff vacancies at foreign agency posts as part of its identification of high-risk areas needing improvement. A new GAO report notes that as of 7/2016, 46% of FDA foreign offices’ authorized positions, including those conducting medical product investigations, were
FDA Policy/General
Federal Register Notice: FDA has issued an order debarring Karis Copper Delong for a period of 12 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Delong was convicted of four
Drugs
FDA has approved a Perrigo ANDA for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5mg/1.5mg per 5mL, indicated for the symptomatic relief of cough in adults and children six years of age and older. Annual sales for the product are about $16 million.
Drugs
The Clinical Trials Transformation Initiative (CTTI) has released new recommendations to streamline and improve pediatric trials in antibacterial drug development. Regarding pediatric drug development planning, CTTI recommends that sponsors engage with FDA to begin pediatric studies as early in drug development as possible to ensure a clear understanding of FDA
Drugs
FDA has posted an International Council for Harmonization guideline on “Q11 Implementation Working Group Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers (regarding the selection and justification of starting materials.” The document was prepared in response to clarification requests on how to implement
Drugs
Alliance for a Stronger FDA has completed its annual agency budget analysis and has determined FDA needs $2.8 billion or 3% ($78 million) more in FY 2018 than the amount appropriated in FY 2016 and available to the agency under the FY 2017 continuing resolution. The 3% increase is
FDA Policy/General
Federal Register Notice: FDA’s Cincinnati District is co-sponsoring with Xavier University a public conference 3/15-17 entitled ‘“FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” Topics to be discussed include How Big Data and Artificial Intelligence Can Enhance Your Proactive Risk Monitoring Programs; Connecting
FDA Policy/General
FDA announced 2/17 the approval of Maryland Heights, MO-based Anzac Animal Health’s Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs. An agency news release said the drug is administered by deep injection into the back muscles. It is used to treat dogs
Devices
FDA has cleared a Medtronic 510(k) of its Signia Stapling System. The device includes “Adaptive Firing” technology that measures the firing force and adjusts the stapler’s speed based on tissue variability measurements, allowing for consistent staple lines, according to the company. “Adaptive Firing technology can detect the variability
FDA Policy/General
CBER’s Advertising and Promotional Labeling Branch says the presentation slides introducing Fenwal’s InterSol (platelet additive solution 3) Solution are misleading because they present efficacy claims but omit all risk information. A just-released 10/14/16 Warning Letter says the violations are concerning from a public health perspective
Drugs
Three staffers in the CDER Division of Bone, Reproductive, and Urologic Products say that the Center’s new structured framework for drug benefit/risk assessment “will facilitate a better understanding of the data and uncertainties underlying drug approvals and will make the information more transparent to the public.” Writing in
Drugs
FDA has granted Axsome Therapeutics fast track status for AXS-05 (bupropion and dextromethorphan in combination) for treating treatment-resistant depression. The therapy is currently being evaluated in the STRIDE-1 study, a Phase 3, randomized, double-blind, active-controlled trial. AXS-05 uses Axsome’s technology of combining the
Biologics
FDA has accepted a Mylan and Biocon BLA for MYL-1401H, a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim), indicated for reducing the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with
Drugs
CDER says that it is planning to publish in this calendar year 101 new and revised guidances in 16 categories. The updated guidance agenda lists these categories, with the number of guidances to be published: Advertising (1). Biopharmaceutics (3), Biosimilarity (2), Clinical/Antimicrobial (1), Clinical/Medical (11), Clinical Pharmacology (8)
Drugs
Unger Consulting says that the routine quality system approach to auditing can frequently fail to identify data management and data integrity problems and a new approach may be needed. In an online paper, the firm suggests that auditors should first focus on data management and data integrity to establish that
Devices
FDA has approved an expanded indication for Medtronic’s Freezor Xtra Cryoablation Catheter — treating patients with atrioventricular nodal re-entrant tachycardia (AVNRT),a life-threatening abnormal heart rhythm. The flexible, single-use device is used to freeze cardiac tissue and block unnecessary electrical signals within the heart. The expanded indication
Drugs
Faced with a backlash over its $89,000 annual price for a decades-old steroidal drug that was recently approved for treating Duchenne muscular dystrophy, Marathon Pharmaceuticals says it has paused its “commercialization efforts” in order to meet with Duchenne community leaders to review their concerns and discuss all options.
Drugs
FDA has approved a Valeant Pharmaceuticals NDA for Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is intended for patients who are systemic therapy or phototherapy candidates who have failed to respond, or have stopped responding to other systemic therapies, an agency news release says. Brodalumab