Information by Drug Class Questions and Answers: Finasteride Label Changes
On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual...
View ArticleClik here to view.
How focus on health and wellness actually hurts medical device firms
Interesting take on the "issue" that improving health may harm Medical Device Firms. Not sure this should be a concern?
View ArticleReport - FDA Strengthens monitoring of Post-Approval Drug Safety
The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to...
View ArticleClik here to view.
FDA Guidance On Dtc Tv Ads Is Unconstitutional?
Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their direct-to-consumer TV ads for agency review. PhRMA, an advocacy group funded by big pharma, complains...
View ArticleClik here to view.
Dietary Supplements: What You Need to Know
How much do you really know about dietary supplements? Some can be beneficial to your health - but taking supplements can also involve health risks.
View ArticleClik here to view.
Litigation As A Drug Safety Risk Index?
Lawyers are responsible for 19% of the Adverse Event Reports filed against big Pharma according to the Institute of Safe Medicine Practicies. These Adverse Event Reports are vital to the FDA's...
View ArticleUK Regulator Draft Guidance Recommends Bayer's Xarelto For Blood Clots
The drug, which is being co-developed by Bayer and U.S. drug maker Johnson & Johnson (JNJ), is a rival of Boehringer Ingelheim GmbH's Pradaxa.
View ArticleFDA adds pancreatitis warning to Januvia label
The FDA has revised the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin), adding information about reported cases of acute pancreatitis in 88 cases. The...
View ArticleAcetaminophen Toxicity
Liver injury from acetaminophen overdose remains a serious public health problem despite ongoing regulatory and educational efforts over the past several years to improve the safe use of medicines that...
View Article
