Brenda Sandburg
Senior Editor

Latest From Brenda Sandburg
Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem
As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.
Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
Pharmacies Likely To Cease Prescribing COVID-19 Therapeutics With End Of Public Health Emergency
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.
FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.
FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.
Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?
Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.