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 FDA will hold a public meeting Dec. 11 to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory.
Promotional materials for two of Ligand's cancer drugs are misleading because they lack risk information for the drugs, overstate their effectiveness and broaden their indications, the FDA said in a warning letter.
Eli Lilly, Pfizer and Bristol-Myers Squibb (BMS) have joined AstraZeneca as targets of subpoenas from the California Office of the Attorney General (AG) over marketing practices for top-selling antipsychotic drugs.
The European Patent Office (EPO) issued an opinion upholding Pfizer's Lipitor patent, siding with the company in a patent infringement case filed by generic drugmaker Ranbaxy.
Industry groups are criticizing a recent activist report on the state of the Medicare prescription drug plan as a ploy to get direct government negotiation of Medicare costs, a move they say will limit consumers' choices.
At the request of Ortho-McNeil, a Johnson & Johnson (J&J) subsidiary, a court has issued a preliminary injunction against Mylan's generic topiramate product.
The U.S. District Court for the District of Massachusetts has denied Roche's request to dismiss a patent lawsuit brought by Amgen and also denied a motion for Ortho Biotech to intervene as a co-plaintiff in the case, according to Amgen.
The drug, biologics and device industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says.
The FDA is working with the Nano Science and Technology Institute (NSTI) to address concerns about potential health and environmental risks from nanotechnology at a summit scheduled for 2007.