ANDAs and 505(b)2 Applications/ Head Lice Infestation/ Tropical Disease Priority Vouchers/ Abuse-Deterrent Properties of Opiods

1. Abbreviated New Drug Applications and 505(b)(2) Applications – Final Rule

This rule implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and revises and clarifies FDA regulations relating to 505(b)(2) applications and ANDAs in a manner intended to reduce unnecessary litigation, reduce delays in the approval of 505(b)(2) applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic drug manufacturers.

Federal Register Notice

2. Head Lice Infestation: Developing Drugs for Topical Treatment; Guidance for Industry

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency’s current
thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation.

Guidance Document

Federal Register Notice

3. Tropical Disease Priority Review Vouchers; Guidance for Industry

There has been significant outside interest in FDA’s interpretation of the priority review voucher section in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Food and Drug Administration Amendments Act (FDAAA). This section makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the FD&C Act. This guidance explains to internal and external stakeholders how FDA is implementing the provisions of this section.

Guidance Document

Federal Register Document

4. Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products

The FDA is holding a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. The meeting will also provide an opportunity to discuss FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. FDA is seeking input from all stakeholders, including patients, health care providers, health care payers, the pharmaceutical industry, patient advocates, academics, researchers, and other government entities.

Individuals seeking to attend the meeting must register by October 17th, 2016. The public meeting will be held on October 31, 2016, from 8:30 a.m. to 4:30 p.m. and November 1, 2016, from 8:30 a.m. to 4 p.m. at College Park Marriott Hotel and Conference Center, 3501 University Blvd. East, Hyattsville, MD 20783.

Meeting Information