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The Texas Health and Human Services Commission (HHSC) has decided to exclude Eli Lilly’s Zyprexa antipsychotic medication from its preferred drug list as a means of reducing state Medicaid spending.
Drug industry representatives are blasting an FDA proposal that would require drugmakers to collect race and ethnicity data for postmarket adverse event reports (AERs), claiming that the requirement would impede reporting efforts and be of little scientific value.
Time limits for drugmakers to begin dispute resolution (DR) proceedings with the FDA following facility inspections aren’t long enough and place manufacturers at a disadvantage that is likely to result in incomplete DR requests, PhRMA recently told the agency.
In an effort to address mounting concerns over counterfeiting, the FDA's Counterfeit Drug Task Force issued a final report last month urging drugmakers to adopt electronic track-and-trace technology and other authentication tools by 2007.
The National Association of Boards of Pharmacy (NABP) has released a list of drugs most likely to be targeted by counterfeiters -- a list the FDA says will have great value in its battle against the distribution of fake drugs.
Some 48 members of Congress have sent FDA Commissioner Mark McClellan a letter urging him to approve OTC status for the emergency contraceptive Plan B before leaving his current post to take the reins at the Centers for Medicare & Medicaid Services (CMS).
Unsubstantiated comparative product claims can increase the risk of FDA off-label enforcement actions by increasing the incentive for a drugmaker’s competitors to complain to the agency, according to a pharma enforcement expert.
The FDA's Office of Combination Products met the time requirement for assigning combination products to agency centers in 100 percent of the requests it received over a seven-month period, the office said in its first annual report to Congress released Friday.