At the end of the day, it's up to pharmaceutical executives to ensure medical products are approved by the appropriate agencies and marketed appropriately.
However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency.
At best, not following these regulations result in submissions not being approved or approval being delayed along alongside revenue dips and increased costs. At worst, it can result in a company receiving warning letters and being subject to other disciplinary actions.
With these challenges in mind, many pharmaceutical executives choose to enlist the expertise of a consulting firm that specializes in compliance with regulatory guidelines.
Firms like these provide a variety of regulatory services that enable executives to get pharmaceutical products on the market more quickly, ensuring that the appropriate regulations are followed.Continue Reading
While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program.
There are many advantages to an MDSAP for both the medical device manufacturer and regulatory authorities.
Developed by the International Medical Device Regulators Forum (IMDRF), the MDSAP is still being evaluated to determine feasibility and the effectiveness of a single quality audit.
When fully implemented, the MDSAP has the potential to greatly impact the medical device quality auditing environment.Continue Reading
Sections 503A and 503B are significant new laws pertaining to the compounding of pharmaceuticals.
As such, any pharmaceutical that manufactures compounded substances or ingredients should understand what they are and how they apply to their operation.
We've answered some basic questions regarding these new laws below: