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 issued warning letters in May to three U.S. distributors of more than 65 kratom products for sales of unapproved new drugs claiming effectiveness in treating opioid addiction and withdrawal. Read More
Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Read More
The FDA released final guidance Monday on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily. Read More
In three of the cases, it recommended less addictive alternatives be given; it suggested one to 15 pills after 11 of the procedures and no more than 16 to 20 tabs after six of them. Read More
A Johns Hopkins University panel has released guidelines for prescribing opioids after 20 common surgical procedures, noting that post-op overprescribing been a major driver of the nation’s addiction crisis. Read More
Two Democratic senators slammed HHS Secretary Alex Azar for blaming pharmacy benefit managers and drug distributors — and letting manufacturers off the hook — for high drug prices. Read More
Drug manufacturers set higher prices even when rebates for pharmacy benefit managers decrease, contradicting allegations that rebates may help drive the increases, according to a new report released by the Pharmaceutical Care Management Association (PCMA). Read More