Drugs
Investors and Duchenne muscular dystrophy patients and their families are cheering the departure of CDER Division of Neurology Products clinical team leader Ronald Farkas, who joined clinical research organization Parexel 9/9. Farkas was one of the harshest critics of Sarepta’s NDA for Duchenne drug eteplirsen during an April
FDA Policy/General
Federal Register Notice: FDA has canceled an 11/16-planned meeting of the Vaccines and Related Biological Products Advisory Committee that was scheduled to review a hepatitis B vaccine manufactured by Dynavax. FDA says the cancelation will allow time for the agency to review and resolve several outstanding issues. A
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval for parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertains to use of the procaine penicillin component for production indications in swine. The withdrawal is being taken at the sponsor’
Drugs
A new Government Accountability Office report finds that generic drug prices fell 59% from the first quarter of 2010 through the second quarter of 2015. However, the report says, a group of 1,441 established generic drugs saw increases after their prices first declined. “More than 300 of the 1,
FDA Policy/General
Continuing its investigation into the FDA Office of Criminal Investigations (OCI), Reuters says that OCI agents routinely share details about criminal matters pending before grand juries with more than two dozen top agency officials. The news service says the “headquarters alerts” let the executives know about expected actions inside or
Drugs
A new Manual of Policies and Procedures (MAPP) describes the organizational structure, roles, and responsibilities of the Drug Safety Oversight Board (DSOB) and its staff within CDER. The document says the DSOB was created in 2005 to provide oversight for the management of drug safety issues in FDA and to
Drugs
The next U.S. president should ask Congress to roll back a number of monopolies granted to the drug industry over the years in a move to make drugs less costly. That’s the recommendation of retired intellectual property attorney and generic drug industry counsel Alfred Engelberg, who was instrumental
Drugs
Three FDAers say their content analysis of prescription oncology drug Web sites directed to consumers and healthcare professionals showed that the sites contain a large amount of quantitative information about the drugs’ risks and benefits. Writing in the Journal of Cancer Education, the researchers say they analyzed the content of
FDA Policy/General
Federal Register Notice: FDA is seeking comments on establishing appropriately targeted durations of use for antimicrobial drugs which are important for human use, when they are administered in the feed or water of food-producing animals for therapeutic purposes. The request for comments is part of the government’s National
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says that Web sites operated by Durect Corp. and Pain Therapeutics Inc. are promoting Remoxy ER (oxycodone) extended-release capsules, an investigational new drug, as being safe and effective for the purposes for which it is being investigated. A 9/8 Notice
Devices
Attorney Cliff Rieders (Rieders, Travis) says the Supreme Court has laid out several types of state law tort claims about medical devices that are preempted by federal law. In a Legal Intelligencer blog post (free subscription required) that traces medical device preemption relating to products approved through PMAs and 510(
FDA Policy/General
After a 24-year career, FDA Division of Import Operations director Domenic J. Veneziano has left the agency to join international trade and regulatory law firm Sandler, Travis & Rosenberg as an independent FDA regulatory and strategic consultant. In his new role, Veneziano will provide advice to producers, importers, exporters
FDA Policy/General
Several public health groups have petitioned FDA asking that it withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. Antibiotic sales to the livestock industry have grown in recent years, despite the agency’s request for the industry to
Drugs
The Washington Legal Foundation (WLF) has asked the 8th Circuit Court of Appeals to overturn a Missouri federal court decision that said plaintiffs who lived outside of Missouri could still sue Pfizer there alleging damages from taking the company’s Lipitor. The WLF amicus brief says that the claims alleged
Drugs
Array BioPharma has reached agreement with FDA on a special protocol assessment (SPA) for BEACON CRC, a global Phase 3 trial involving encorafenib and Erbitux (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line
Drugs
Three Pepper Hamilton attorneys say that an FDA 5/31 decision awarding Amarin Pharma five years of new chemical entity (NCE) exclusivity for its Vascepa overturned the agency’s previous rejection of NCE exclusivity due to a DC federal court ruling that vacated and remanded the FDA administrative decision. “The
Drugs
FDA has published an International Council on Harmonization draft guidance, Q&As on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies, with questions and answers on the assessment of systemic exposure in toxicity studies. The document says it focuses on points to consider before
Devices
CDRH has denied a Germaine Laboratories petition that sought an exemption from premarket notification requirements for “method, metallic reduction, glucose (urinary, non-quantitative)” devices that are in reagent tablet form. Currently, the devices are in Class 2 and referred to as “copper reduction tablet tests.” The devices are intended for
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Pharmacy of Illinois, Inc. (dba Alwan Pharmacy and Compounding Center) Peoria, IL (7/22). FDA investigator inspected drug compounding operation and observed serious deficiencies in its practices for
Devices
FDA has granted EBR Systems an Investigational Device Exemption for its WiSE (Wireless Stimulation Endocardially) technology for cardiac resynchronization therapy (CRT). The company says it is now planning a major U.S. study to establish safety and effectiveness data to support FDA approval. The company says about 30% of patients
FDA Policy/General
Federal Register notice: FDA has released a guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The document provides establishments that make donor eligibility determinations for donors
Devices
FDA has approved a Carl Zeiss Meditec PMA for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. The device removes a small amount of eye tissue to permanently reshape the cornea, according to