The U.S. Food and Drug Administration (FDA) announced plans to withdraw the approval of 249 Abbreviated New Drug Applications (ANDAs) since their manufacturers have failed to submit annual reports. This should serve as a...more
The Food and Drug Administration (FDA) recently enhanced its Paragraph IV (PIV) Certifications List with additional data fields. The PIV Certification List regularly publishes information regarding the 180-day exclusivity...more
The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent...more
The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications. Both sections were added to the FD&C Act...more