FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018.
We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of these forms is to download new copies directly from the FDA Forms page on FDA’s website. If you already have...
Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.
In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it can be difficult to tell if you have the current version of these forms because FDA did not update the expiration date for either document.
The Affordable Care Act requires pharmaceutical companies that dispense drug samples to physicians and health care professionals to report annually on the details of the samples dispensed. The government mandated this electronic reporting of all drug samples annually, by April 1 each year. The intent of the legislation is to help FDA monitor prescription drug distribution activity and prevent abuse.