We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Industry group says that even though the FDA’s promulgation of three draft guidance documents on risk assessment and minimization will go a long way in establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs.
The FDA cited five dietary supplement manufacturers for marketing and distributing ASN Canthaxanthin and Universal Canthaxanthin tablets as anticancer agents without approval from the agency.
Several senators are calling for the creation of a national registry of drug trials that would considerably expand the scope of the existing database at clinicaltrials.gov. The calls follow delays by pharmaceutical manufacturers in reporting the results of their clinical drug trials to a federal government website.
The FDA’s director of pharmacy affairs is warning that, if a provision passed by the House barring the agency from spending federal money to block FDA-approved drug importation were to take effect, the doors might be opened to drug counterfeiters.
Five dietary supplement manufacturers have been cited by the FDA for marketing and distributing ASN Canthaxanthin and Universal Canthaxanthin tablets as anticancer agents without approval from the agency.
An FDA analysis of purported generic versions of three popular Rx drugs purchased from a website advertised as Canadian revealed the products to be potentially dangerous, according to the agency.
The House has approved a measure to penalize the FDA’s Office of Chief Counsel for defending drug manufacturers in lawsuits brought by families of patients who died using the companies’ products, and for attempting to deceive Congress about ties the agency’s chief counsel had to the industry.
As the debate over prescription drug prices continues to rise in volume and intensity, the impetus to allow the importation of drugs from other countries into the U.S. appears to be reaching its peak.
A joint FDA advisory committee has recommended the agency not approve Allergan’s oral retinoid treatment for psoriasis, saying that although the treatment demonstrated modest efficacy in pivotal trials, the accompanying risk management program is inadequate.
The FDA is on track to approve more new molecular entities (NMEs) this year than it did last year. For the first six months of 2004, the FDA approved 12 NMEs, compared to only seven for the comparable period in 2003 and 17 NMEs for all of 2002.