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.
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More
The FDA does not intend to object to an institutional review board waiving informed consent requirements for certain clinical investigations considered to be “minimal risk,” according to a new agency guidance effective immediately. Read More
The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects. Read More
In response to an increased demand for unit-dose repackaging of solid oral dosage form drugs, the FDA released new draft guidance that would allow extended expiration dating for repackaged unit-doses. Read More
The Drug Enforcement Administration is proposing to lower its annual manufacturing limits on certain controlled substances for 2018 — which would cut back production of several classes of opioid painkillers and other scheduled pharmaceuticals, some between 10 and 25 percent. Read More
The development of a vaccine to treat addiction represents an “incredibly exciting” initiative in the nationwide fight against opioid abuse, HHS Secretary Tom Price said Tuesday. Read More
Under the decree, Isomeric Pharmacy Solutions is prohibited from storing, processing, manufacturing or distributing drugs until it complies with FDA regulations. Read More