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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).
The FDA has issued a question-and-answer draft guidance that clarifies changes made by the Medicare Modernization Act (MMA) in relation to the generic-drug approval process.
The FDA has released a compliance policy guidance to assist pharmaceutical manufacturers with the implementation of radio-frequency identification (RFID) feasibility studies and pilot programs to strengthen the U.S. drug supply chain and to promote the widespread use of RFID technology by 2007.
Manufacturers designing clinical trials for vertebral augmentation devices should pursue a randomized study with a follow-up period of at least two years, according to a new FDA guidance document.
The FDA will adopt a three-pronged surveillance and quality assurance strategy to improve the predictability and consistency of the agency’s scientific evaluations of dietary supplements and the safety of the products’ ingredients.
The FDA plans to formalize an improved process to ensure the opinions of its scientific reviewers are incorporated into the agency's decisionmaking process, according to a new initiative to strengthen the FDA's safety program for marketed drugs.
The development of new biomarkers and standardizing clinical trial data-gathering should be initial focuses of the FDA’s Critical Path Initiative, which aims to expedite the drug development process and bring more products to market faster, according to the FDA’s Science Board.
Despite an increase in the manufacturing costs for some generic drugs, these costs for the most part are not being passed along to patients, according to a study by AARP.