In anticipation of the
Broadly,
Based on
In FY 2024, FDA aims to:
Strengthen
FDA hopes to propose amendments to the FDCA to grant FDA new authority to establish binding contamination limits in infant and young children's foods.
Create Product Testing Requirements for Foods Marketed for Consumption by Infants and Young Children
FDA would also like to propose an amendment to the FDCA that requires industry members to conduct toxic-element testing of final products marketed for infants and young children and maintain records of these test results for FDA inspection.
Modernize the
FDA seeks to provide a transparent marketplace, help facilitate risk-based regulation of dietary supplements, and clarify
Drugs
In FY 2024, FDA aims to:
Amend the FDCA 180-day Exclusivity Provisions to Encourage Timely Marketing of First Generic
FDA aims to propose revisions to the FDCA to specify that 180-day patent challenge exclusivity for generic drugs does not block approval of subsequent applications from other generic drug manufacturers until a first applicant begins commercially marketing the drug.
Explicitly Address Generic Drug-Device Combination Products in the FDCA
FDA hopes to propose amendments to the FDCA to explicitly address the submission and review of Abbreviated New Drug Applications (ANDAs) for drug-device combination products, as well as drug products submitted in an ANDA that are used with a device, but which are not submitted as combination products.
Require full ingredient disclosure for drugs to promote generic competition
Create a Safe Harbor for "Skinny Labeling"
"FDA would like to create a safe harbor from patent infringement liability for human and animal generic drug applicants and 505(b)(2) applicants who market a drug with "skinny labeling."1
FDA seeks to expand
Enhance Authority Regarding Post-Market Safety for Animal Drugs
FDA is proposing that the FDCA be amended to authorize the
Change Agency Regulatory Oversight Responsibility for Certain Products
FDA hopes to propose an amendment to the definition of "new animal drug" in the FDCA to provide the ability to exclude certain products or classes of products that FDA and the
Enhance Availability of Generic Animal Drugs
FDA would also like to propose amendments to the FDCA to clarify labeling requirements for generic animal drugs.
Animal Biologics
In FY 2024, FDA aims to:
Enact a structured and tiered risk-based framework for animal biologic products subject to FDA regulation.
All FDA-Regulated Products
In FY 2024, FDA aims to:
Obtain Authority to Require Destruction of Imported Products That Present a Significant Public Health Concern
FDA would like to propose amending the FDCA to give FDA the authority to require an owner or consignee to destroy any FDA-regulated product offered for import that has been refused entry and presents a significant public health concern, removing their option to export the product under the current FDCA framework.
Obtain Authority to Require Retention of Data and Records Supporting Marketed Medical Products and Product Applications and to Act Upon Submissions Containing Fraudulent or Unreliable Data
FDA wants express authority to ensure that data supporting application and nonapplication medical products are reliable and verifiable for as long as the product may be legally marketed.
Tobacco Products
In FY 2024, FDA aims to:
Modernize the tobacco user fees framework. FDA seeks authorization FDA to assess user fees on, and collect fees from, tobacco manufacturers and importers through a proposed FDCA amendment.
PAHPA
In FY 2024, FDA aims to:
Amend PAHPA After the COVID-19 Pandemic Exposed Weaknesses in Current Legislation
These proposals, among many others, aim to support
Footnotes
1. Skinny labeling is an exception to the FDA requirement that generic labeling be identical to the brand-name drug's labeling as the generic manufacturer must "carve out"—or exclude—from the labeling, diseases or patient populations that remain protected by use patents.
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