We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Although there has been increasing rhetoric about addressing high drug prices as a trade matter rather than resorting to measures such as importation, U.S. trade representatives can do little more than encourage other countries to abandon their systems of price controls, trade officials told a congressional panel last week.
Since new drug patent rules went into effect last year, the FDA has not received a single polymorph patent for filing in the Orange Book, according to agency officials, who are seeking input on implementing the changes to the Hatch-Waxman Act patent law.
The FDA has ordered all manufacturers of exocrine pancreatic insufficiency drug products (PIDs) to submit new drug applications (NDAs) to the agency and have them approved within the next four years if they expect to remain on the market.
Florida-based devicemaker Diomedics has found itself in the FDA’s cross hairs for allegedly promoting and distributing an infrared tissue-heating device using marketing claims beyond the product’s intended use.
Women with breast implants are exposed to a serious risk of implant rupture during the compression phase of mammograms used for breast cancer screening, indicates a new FDA study.
Kentucky-based devicemaker KBD has been cited by the FDA for quality system regulation (QSR) violations in connection with its manufacture of Class II phototherapy lamps.
AdvaMed contends that the FDA's recent white paper examining the state of innovation in the medical products industry painted a bleaker picture of devicemakers than what actually exists.
Failing to comply with FDA good manufacturing practices (GMPs) can lead to losses of money and time as surely as straying outside the legal boundaries regarding fiscal responsibility can — a reality that needs to be reflected in the priorities of manufacturers' boardrooms, according to a compliance and quality management expert.
The FDA has told Novartis to stop circulating a professional sales aid for Diovan tablets containing unapproved claims that the drug helps diabetics and patients with hypertension to maintain proper renal function.