 |
CCH NetNews™ |
|
(July 6, 2010)
Food and Drug Law |
|
Continuing to to provide you with the most up-to-date, accurate information, CCH introduces new enhancements for the Food, Drug & Cosmetic Reporter and the Medical Devices Reporter. These include:
The Food, Drug & Cosmetic Reporter provides everything you need to know about Food and Drug Regulations. Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics.
Order Your Subscription Today »The Medical Devices Reporter provides access to the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices.
Order Your Subscription Today »
To access the CCH® Internet Research Network™ (IRN) full text documents you must be a subscriber to the Medical Devices Reporter or Food, Drug and Cosmetic Law Reporter, IRN product (depending on the link).*
Links within news stories display full text documents including legislation, regulations, court decisions, rulings and government reports.
The first time you click on a link you will be taken to the IRN login page, where you will need to enter your ID and password. Subsequent links will take you directly to the desired document.
If you aren’t a subscriber call 800-449-9525 or let us contact you about the Medicare and Medicaid Guide.
Signing up for a 7 day free trial will allow you to click on the links within the news stories and see the full text documents.
Two guidances providing recommendations for industry on developing human drugs, therapeutic biological products, and medical devices for the treatment of systemic lupus erythematosus (SLE), including lupus nephritis (LN) outcomes, were published by the FDA. In the first guidance titled “Lupus Nephritis Caused By Systemic Lupus Erythematosus—Developing Medical Products for Treatment,” the document provides information for sponsors in the clinical development of medical products for the treatment of LN caused by SLE. Specifically, the document addresses study population enrollment and efficacy endpoints for LN trials. In the second guidance titled “Systemic Lupus Erythematosus—Developing Drugs for Treatment,” the agency discusses the indications that it may be willing to approve at present for new drug therapies for lupus. According to the FDA, progression to end-stage organ involvement continues, because many patients have incompletely controlled the disease, and current therapies and treatments carry potential risks of debilitating side effects. The agency noted the importance of clearly describing acceptable endpoints for approval to facilitate the development of novel therapeutic agents that would have the potential to be more effective or less toxic.
Chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes with minimal potential to have adverse effects on product quality may be reported by applicants in an annual report were provided in a draft guidance published by the FDA. Titled “CMC Postapproval Manufacturing Changes Reportable in Annual Reports,” the draft document provides recommendations to holders of new drug applications and abbreviated new drug applications regarding the types of changes that may be reported in annual reports.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
On June 23, 2010, the declaration of emergency that was issued by FDA justifying the emergency use authorization (EUA) of in vitro diagnostic devices, personal respiratory protection devices, and antiviral products from the neuraminidase class of antivirals oseltamivir phosphate, zanamivir, and peramivir was terminated by the agency. According to the FDA, for any patient who began a treatment course of peramivir prior to June 23, 2010, the authorization will continue to be effective after June 23, 2010, to allow completion of that treatment course, to the extent the patient’s attending physician finds continued treatment necessary.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
Delalutin® (hydroxyprogesterone caproate) held by Bristol-Myers Squibb and originally approved for the (1) treatment of advanced adenocarcinoma of the uterine corpus; (2) management of amenorrhea (primary and secondary); and (3) abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology was not withdrawn from sale for reasons of safety or effectiveness as determined by the FDA. The product was withdrawn because the drug has not been commercially available for a number of years. The determination means that FDA will continue to approve abbreviated new drug applications (ANDA) that refer to the products. The drug products will continue to be listed in the “Discontinued Drug Product List ” section of the FDA's Orange Book. Future applicants who are unable to find Delalutin® for bioequivalence testing should contact the FDA’s Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.
FDA Notice.Read IRN» (ip access user) » (Read Intelliconnect) »
© 2010 CCH. All Rights Reserved.
To opt out of this newsletter or to make changes to your email preferences click here.
contactus@wolterskluwerlb.com
