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Ranbaxy Laboratories plans to conduct new clinical studies in North America for its generic antiretroviral fixed-dose combination (FDC) HIV treatments to definitively establish their bioequivalence, company officials said.
The FDA will commission the Institute of Medicine of the National Academies to evaluate the U.S. drug safety system and assess the FDA's role in delivering safe and effective drugs to the public, the agency announced November 7.
Controversies surrounding the FDA's role in the handling of several recent high-profile cases could lead to greater congressional oversight of the agency, according to some Washington observers.
Generic biologics can be approved without violating the Fifth Amendment’s “takings clause,” despite brand manufacturers’ claims that their property rights are absolute, according to the Generic Pharmaceutical Association (GPhA).
In another assault of dietary supplement labeling claims, the FTC has filed complaints against six companies for making false weight-loss claims for their products in advertisements featured in national media outlets.
Generic biologics can be approved without violating the Fifth Amendment’s “takings clause,” despite brand manufacturers’ claims that their property rights are absolute, according to the Generic Pharmaceutical Association (GPhA).
The U.S. could force a delay in the implementation of its free trade agreement (FTA) with Australia if that country’s government fails to deal with amendments to the pact that could impose fines on pharmaceutical companies attempting to extend their patents, according to U.S. trade officials.
The nation’s generic firms and prescription purchasers are in for a bleak future if current and proposed Bioshield legislation is not handled properly, the Generic Pharmaceutical Association (GPhA) warned.
The Division of Bioequivalence (DBE) in the FDA’s Office of Generic Drugs hopes the addition of more reviewers will help reduce the long wait for generic drug application approvals, according to the division’s chief.