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The FDA wants to ensure that drugmakers and other sponsors of clinical trials for new drugs that treat serious or life-threatening diseases provide more information about the trials to patients who may not meet the study’s eligibility criteria.
A joint FDA/U.S. Customs and Border Protection investigation that found drugs exported from Canada into the U.S. often are manufactured in countries such as Mexico, Pakistan, India and Costa Rica could help the agency in its fight against state and local government reimportation efforts.
Drugmakers have identified several improvements they would like to see made to interim rules adopted last month for the transitional Medicare drug discount card.
The FDA’s Office of Generic Drugs (OGD) is bracing for a record number of applications this year, and hopes not only to meet the increasing workload but to actually speed generic approvals.
Purdue Pharma has petitioned the FDA to withhold final approval for a version of its profitable pain drug OxyContin until generic firms implement appropriate risk management plans (RMPs) — a move that could delay generic competition.
Andrx has received conditional approval for its new mania and seizure treatment valproate delayed-release tablets, which is similar to brand firm Abbott Laboratories’ profitable drug Depakote.
The FDA’s decision to award Alpharma subsidiary Purepac 180-day marketing exclusivity for a generic version of Pfizer’s epilepsy drug Neurontin (gabapentin) has been upheld by a federal appeals court.
While reforms to the Hatch-Waxman Act aim to cut down on abuses of the drug patent system, a provision in the law may still let brand firms delay generic competition by simply not listing all of their patents in the FDA’s Orange Book.
French drugmaker Aventis yesterday recommended that shareholders reject an unsolicited $60 billion acquisition bid from smaller French rival Sanofi-Synthelabo, arguing the offer undervalues the firm.
Drugmakers’ consumer education, disease management and patient compliance websites that allow individuals to submit private information can expose manufacturers to FTC enforcement actions if security measures are insufficient, according to an FTC attorney.