Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
A diagnostic test designed to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever has been approved by the Food and Drug Administration, the Centers for Disease Control and Prevention announced Thursday.
The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.
Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.
The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.
The Council for Responsible Nutrition on Thursday issued a response to a U.S. Preventive Services Task Force draft recommendation around the ineffectiveness of vitamin D and calcium to prevent cancer or fractures.
GlaxoSmithKline has received regulatory approval from the Food and Drug Administration for a vaccine designed to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B.
Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.
As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.
With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.
Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.
The Food and Drug Administration on Thursday warned parents against administering benzocaine to their teething babies and advised that parents not use benzocaine at all in children under the age of 2 years unless under the supervision of a family physician.