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The long-awaited interim final rule on drugmakers’ submissions of average sales price (ASP) data does little to flesh out the generalities of the Medicare Prescription Drug, Improvement and Modernization Act regarding how to calculate ASP.
The FDA will release in August a multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
In a move that could have significant impact on the bottom lines of original equipment manufacturers, the California Department of Health Services (CDHS) is endorsing the highly controversial practice of reprocessing single-use devices (SUDs).
Physicians, researchers and others who plan, teach or write continuing medical education (CME) programs must tell program attendees if they have had financial ties to drugmakers during the preceding year, under updated standards for commercial support adopted by the Accreditation Council for Continuing Medical Education (ACCME).
Corixa has been ordered by the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) to immediately cease distribution of a promotional video for its combination cancer treatment and provide the agency with a plan of action to correct misleading safety and efficacy claims made in the video.
An International Conference on Harmonisation (ICH) draft guidance issued by the FDA can assist biological and biotechnological drugmakers in designing studies to assess whether changes in manufacturing processes adversely affect the quality, safety and efficacy of the product.
The FDA has released an International Conference on Harmonisation (ICH) pharmacovigilance draft guidance that outlines ways drugmakers can summarize the identified risks of a drug, the potential for unidentified risks, possible at-risk populations, and situations that have not been studied preapproval.
Several dietary supplements produced by manufacturer Reality Health Research (RHR) are drugs based on the company’s claims that the products prevent and cure a host of diseases, the FDA said in a warning letter.
Devicemakers looking to expand their manufacturing operations through the purchase of new or existing building structures need to focus on a number of important factors to ensure the facility meets their business needs, according to industry experts specializing in project management and site design.
The FDA has released an international draft guidance to help makers of biological and biotechnological drugs design studies to assess the comparability of products before and after changes are made to the manufacturing process. Such studies determine whether a manufacturing change adversely affects the quality, safety and efficacy of the product.