An Overview of Cosmetic Labeling in the USA
A label is an essential feature of a cosmetic product as it serves multiple functions:
A label is an essential feature of a cosmetic product as it serves multiple functions:
Medical device labeling is a critical part of any device. It provides information to the consumer in textual or graphic forms on the packaging. It intends to increase the safety and usage instructions for consumers. When there is a false or misleading label, it is regarded as a misbranded medical device or adulterated medical device. It is considered a legal offense when a device fails to report essential product information based on its judicial requirements.
In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in drug labeling for ready-to-use containers in New Drug Applications (NDAs), Biologics License Applications (BLAs), or supplements to those applications.
In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs. It addresses the statement of identity and drug strength for OTC products.
A drug therapy regimen is diverse for drugs that can be approved to be used in combination with a previously approved drug or simultaneously developed two novel drugs, that synergistically enhance efficacy. Single-drug cancer therapies significantly showcased drug resistance as a major threat for patients undergoing treatments with anti-cancer drugs. Considering the diversity in combination therapy adopted for cancer treatments, two-drug regimens are gradually replacing monotherapy as a standard of care in patients.
As the world is moving towards digital transformation, the introduction of various tools is empowering many industries, including Pharmaceuticals and Life Sciences. In fact, the serialization and traceability of items can be improved even further as the world transitions to a digital economy. Currently, traditional approaches for achieving traceability in the Pharmaceutical Supply Chain are frequently centralized and sometimes lack transparency among supply chain participants.
In the era of personalized medications, precision medicine revolutionized the delivery of biologicals, ensuring safety and efficacy by comprehending the product’s effect at an individual level. Pharmacogenomics (PGx) is one of the components of precision medicine owing to its role in optimal dose selection and effective, dose-responsive, individual identification that can avoid adverse reactions.
A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product. SmPCs, classified as short-form advertisements, are ratified and approved by the European Medicines Agency (EMA) or the Medicines and Healthcare Products Regulatory Agency (MHRA).
With an increase in self-medication, the demand to have drug labels provide as much information as possible is growing. In the pharmaceutical industry, customers and patients must be protected by a clear, concise label that provides information about medications. Drug labels must provide customers with a way to know more about their formulas, how they are used, and what to do if there is a medical emergency.
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
We have come a long way in the journey of Product Information (PI) and Quality Review Documents (QRD) since then.