Familiarize yourself with the new FDA draft guidance on blood pressure response which carries important implications for drug developers.
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
Why you should prepare now even with nearly a year remaining.
What can you do during your study to maximize your chances of success when it comes time to submit?
Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?
Regulatory experts outline some of the regulatory changes on the horizon for the medical device industry.
Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.
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