As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA applicants in their business decisions to pursue generic drug development. The list will now include, on a prospective basis, the following information:
- Number of potential first applicants
- 180-day decision status
- Date of first “first applicant” approval
- Date of first commercial marketing
- Expiration date of last qualifying patent
For further information, please see the FDA’s Patent Certifications and Suitability Petitions website.
The FDA has posted a website regarding products containing cannabis or cannabis-derived compounds, and particularly cannabidiol (CBD), articulating their current position and 4 specific points they are working to learn more about. The webpage includes a link to a public docket the FDA is using to gather information and data. The docket is available for comment until 16 July 2019. The agency has consistently stated, however, that it believes that CBD is not a legal ingredient in a food or a dietary supplement because it has been investigated as a Investigational New Drug (IND) and has been approved for use in the drug Epidiolex.
Effective 17 June 2019, the FDA is making pre-assigned ANDA number requests available via the CDER NextGen Portal.
Guidance Document updates on the FDA website
- Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework
The purpose of this guidance is to describe the benefit-risk assessment framework that the Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act.
- Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment
This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the important components of a drug development program for compensated NASH cirrhosis.
CDER & CBER
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications
This guidance details the information that should be provided in each section of the common technical document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission.
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
This guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
This guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER).
- Formal Dispute Resolution: Sponsor Appeals Above the Division Level
This guidance describes the formal dispute resolution (FDR) procedures for sponsors that wish to appeal4 a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes.
- Mouse Embryo Assay for Assisted Reproduction Technology Devices
FDA is issuing this draft guidance to outline draft recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices.
CDRH & CBER
- Testing for Biotin Interference in In Vitro Diagnostic Devices
This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.
- Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
The purpose of this guidance is to help industry subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine the number of employees for purposes of the “small business” definition under parts 117 and 507.
- CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI)
This guidance document represents the Agency’s current thinking on animal products containing ethylenediamine dihydroiodide (EDDI) or feeds containing unapproved new drugs under the provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).