[quote]Doesn't the FDA only oversee the package insert layout format for U.S. Prescribing package inserts, and may time to time review. Someone one else in the pharmeceitcal,company is writing that, and use simlar to the MSDS's package inserts for chemicals.[/quote]

sorry Paul, missed this question

the answer is YES, the pharmaceutical company writes the prescribing information under very strict guidelines. And NO the FDA is not responsible for the layout and format of the document. The FDA is responsible to ensure that every word is scrutinised for accuracy before being approved (hopefully). This includes any changes the company wants to make, any new data to be added and any reviews. If the information is not approved, the product cannot be sold.

there are normally two types of information - one is the information for physicians which contains the approved indication and the other is for patients which contains a shortened version with less mumbo jumbo and more practical advice. Both are submitted and approved by the FDA

There are shortened versions that appear on advertising and internet sites and these may not be approved by the FDA but must be true to the already FDA approved versions. These versions should also direct you to the full version for further information.