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.
Drugmakers that implement selective distribution policies in an effort to combat counterfeiting are likely to get a little help from new guidelines issued by the Health Industry Group Purchasing Association (HIGPA).
The Generic Pharmaceutical Association (GPhA) is questioning whether the FDA can find the additional time and personnel needed to comprehensively review additional in vivo bioequivalency (BE) data required of generic drugmakers under a proposed rule.
The FDA's Counterfeit Drug Task Force is urging drugmakers to adopt electronic track-and-trace technology by 2007, as well as multiple authentication technologies, in order to combat the distribution of counterfeit drugs.
While supporting the FDA’s goal of combating fake drugs, generic manufacturers say counterfeiters are unlikely to target their products because they are inexpensive and generate thin profit margins.
Generic manufacturers say counterfeiters are unlikely to target their drugs because they are inexpensive and generate thin profit margins, and as a result, the products may not require the expensive anticounterfeiting technology recommended last week by the FDA.
The time limitations defined in an FDA draft guidance on dispute resolution would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete, according to PhRMA.
The FDA has recommended that manufacturers adopt electronic track-and-trace technology by 2007 as well as multiple authentication technologies in order to combat the distribution of counterfeit drugs, according to the final report of the agency's Counterfeit Drug Task Force released yesterday.
The FDA’s efforts to close a loophole in enforcement actions on marketed unapproved drugs have pitted one drugmaker that argues the loophole punishes firms that apply for a new drug application (NDA) against another company that says closing the loophole will limit competition and drive up prices for the drugs.
PhRMA believes time limitations defined in an FDA draft guidance on dispute resolution (DR) would place manufacturers at a disadvantage when using the system or result in dispute resolution requests that are incomplete.
The makers of hormone therapy (HT) products need to revise their labeling to include data from a clinical study that found women over 65 had an increased risk of dementia when taking oral conjugated estrogens plus medroxyprogesterone acetate, the FDA said last week.