Despite the unmet need in a fairly large market, no prescription drugs have been developed to treat lactose intolerance...Ritter Pharma's solution is a prescription drug called RP-G28, an oligosaccharide designed to produce colonic adaption, a process that changes the microbiota in the large intestine

PDUFA = Prescription Drug User Fee Act

The draft guidance fulfilled mandates under the Food and Drug Administration Safety and Innovation Act and the Office of National Drug Control Policy's Prescription Drug Abuse Prevention Plan

Besides setting prescription drug and medical device fees for the next five years, the legislation created new user fees for generic and biosimilar drugs

The Prescription Drug User Fee Act date is Sept

Besides setting prescription drug and medical device fees for the next five years, the legislation created new user fees for generic and biosimilar drugs

Yet discovering new pain therapies has been a challenge for the industry despite the obvious huge rewards waiting for those companies that could deliver drugs as effective as opioids minus the qualities that causes prescription drug abuse and safety issues. (See BioWorld Insight, Aug. 13, 2012.) To help address this situation, the public-private partnership Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was formed

PDUFA = Prescription Drug User Fee Act

The report noted that 34 out of the 35 drugs (97 percent) met the target dates agreed to under the Prescription Drug User Fee Act (PDUFA), surpassing its goal of reviewing and acting on 90 percent of new molecular entities (NMEs) by their target dates

Previously, CBO had found insufficient evidence of an offsetting effect of prescription drug use on spending for medical services

Under section XII of the Prescription Drug User Fee Act V performance goals, the FDA also agreed to create a plan for distinct therapeutic area data standards and to prioritize and develop the data standards in collaboration with industry, the Clinical Data Interchange Standards Consortium, the Critical Path Institute, Health Level 7's Clinical Interoperability Council and other organizations

PDUFA = Prescription Drug User Fee Act

The FDA's Office of Prescription Drug Promotion, Division of Professional Drug Promotion, issued a letter to ONY Inc., of Amherst, N.Y., stating that materials on its website are false or misleading because they present unsubstantiated superiority claims for Infasurf, omit important risk information and make unsubstantiated claims for the product

The FDA's Office of Prescription Drug Promotion, Division of Professional Drug Promotion issued a letter to ONY Inc., of Amherst, N.Y., stating that materials on its website are false or misleading because they present unsubstantiated superiority claims for Infasurf, omit important risk information and make unsubstantiated claims for the product

They asked the DEA to establish clear regulatory guidance to ensure that the laws governing prescription drug supplies are applied consistently without threatening the well-being of patients

PDUFA = Prescription Drug User Fee Act

President Obama has signed into law the SAFE DOSES Act, which will increase penalties for prescription drug crimes such as robbing pharmacies and medical product cargo

In separate news, Genentech received a letter from the FDA's Office of Prescription Drug Promotion stating that the visual aids included in advertisements for cancer drug Tarceva (erlotinib) are misleading because they contain "misleading efficacy claims, minimize the risks and overstate the efficacy of Tarceva

President Obama has signed into law the SAFE DOSES Act, a law that will increase penalties for prescription drug crimes like robbing pharmacies and medical product cargo...As well, the bill's sponsors hope to stem the rising tide of prescription drug abuse