News

FDA Solicits Feedback on Drug Products Approved Under Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments

The FDA has established a public docket to solicit comments on several issues related to FDA’s regulation of certain drug products approved under abbreviated new drug applications before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. Because these Pre-Hatch-Waxman ANDAs (PANDAs) were submitted under section 505(b) and approved under section 505(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act, they can serve as a reference listed drug (RLD) for future abbreviated new drug applications submitted under section 505(j) of the FD&C Act (505(j) ANDAs) and can also be a listed drug relied on by 505(b)(2) applications.

Although these PANDAs are 505(b) applications, they have historically been overseen by FDA’s Office of Generic Drugs. FDA is aware that there may be some confusion about the applicability of certain statutory and regulatory provisions to these PANDAs. In particular, there is confusion whether PANDAs are subject to the requirements that apply to other 505(b) applications or to those that apply to 505(j) applications. FDA recognizes there are differences between certain requirements for 505(b) application and 505(j) applications, including with respect to requirements regarding labeling updates, patent listing, eligibility for exclusivity, and certain drug safety-related requirements or procedures.

FDA is seeking input from holders of these PANDAs and other interested persons regarding whether there are regulatory or policy rationales for treating these PANDAs differently from other 505(b) applications in certain respects. To facilitate stakeholder feedback, FDA has included specific questions in the Federal Register Notice. These questions are not meant to be exhaustive, and FDA is also interested in any other pertinent information stakeholders would like to share on this topic. In all cases, FDA encourages stakeholders to provide the rationale and basis for their comments, including any available supporting data and information. Interested persons can submit comments to the docket until December 11, 2021.

Recent News

04/23/2025

Grenova Secures New Investment; Appoints Life Sciences Veteran to the Board

Grenova, Inc., a Virginia-based innovator in sustainable laboratory technologies, today announced two significant milestones for the company: the appointment of Ted Hull to Grenova’s board, and the successful completion of a new round of growth equity capital. These developments support Grenova’s strategic vision to drive innovation, expand automation capabilities, and deliver transformative solutions to laboratories

04/22/2025

Phlow Corp. Expands Analytical Capabilities and Embraces Artificial Intelligence-Driven System, Ushering in a New Era of Modern Medicine Manufacturing in America

Phlow Corp., a leading pharmaceutical contract development and manufacturing organization (CDMO) in America, announced a significant expansion in its analytical capabilities, use of artificial intelligence (AI), workforce, and domestic infrastructure. Marking a period of exceptional growth and momentum, Phlow has more than doubled in size and now employs over 90+ highly skilled scientists and professionals

04/22/2025

ATCC Announces New Executive Leadership Appointments

ATCC, the world’s premier biological materials management and standards organization, today announced several new leadership appointments. Rebecca Bradford, MBA, has been promoted to the role of senior vice president of Government Programs, ATCC Federal Solutions (AFS); Manoj Menon, PhD, has joined the company as chief operating officer; and Rupali Lach was appointed vice president of Commercial Operations.