FDA Commissioner Approval Compliance Approved

Minoxidil is the first and only FDA approved prescription drug for treatment of androgeneric alopecia or male pattern baldness. It is a hypertensive product that has vasolidating properties which feed nutrients, blood and oxygen to the hair follicles. It will then cause follicles to shed and then replaced by new hair growth. Treatments come in 5% and 2% solutions. Concentrated solution of 5%

There are many different software companies out there that provide document control for FDA 21 CFR Part 11 companies. So many to choose from that if you do a simple search on Google for document management there are over 108 million pages you can choose from. So how do you know if they are validated systems? How do you know if they will work for you?There is one easy answer: you decide what v

The only prescription medicines currently approved by the Federal Food and Drug Administration for the treatment of migraines are Depakote (anti-seizure,) Inderal (beta-blocker,) Blocadren (beta-blocker) and Topamax (anti-seizure.) However, many other medications are prescribed by doctors for "off-label use," to treat migraines.What is "off-label" use?"Off-label" use is prescribing a drug int

With the number of recalls and new drug warnings issued lately, the FDA's approval process has been in the news a lot. There have been so many cases of drugs causing problems and what the approval means that there have been a number of Supreme Court cases attempting to determine whether or not the makers of various drugs and medical devices are liable for their products malfunctioning or adve

Recently, the F.D.A., the Food and Drugs Administration in the U.S approved the very first penis extender, which has its roots in Europe, where it has been on the market for the last ten years, originating in Germany before branching out.Unlike most of the devices you see on the market which use certain types of frames which sit at the base of the shaft, extending along it and securing the he

ValidationValidation is required to ensure that a process, system, material, method, product, piece of equipment, or personnel practice, will meet its intended purpose and function or allow functioning in a reliable, consistent manner. A firm derives little benefit if a thorough understanding of validation remains solely within the validation department.After four decades of existence, valida