The U.S. Food and Drug Administration (FDA) recently published new guidance (the Guidance) related to actual or potential medical device shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J...more
It is very likely the U.S. President will soon sign the newly amended United States-Mexico-Canada Agreement (USMCA), which is intended to replace NAFTA. Mexico has already ratified the amended USMCA and Canada is expected to...more
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
There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): traditional, special and abbreviated. Under the recently finalized Safety and Performance Based...more
This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA...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The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications.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
In December 2016, the FDA published an industry guidance related to the Biologics Price Competition and Innovation Act. This guidance offers suggestions to sponsors on the design and use of clinical pharmacology studies to...more
Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more