- Amendment of the Brief Summary
- Presentation of Risk Information in Prescription Drug and Medical Device Promotion
The latter is certainly handy due to the fact that so many Warning Letters have been issued this year because of the lack of risk inclusion in marketing materials.
- The design of adaptive clinical trials – this could provide companies with alternatives and less costly means of testing drugs;
- Immunogenicity assessment for therapeutic protein products – this could have a defining influence on the development of follow-on-biologics, particularly if devised prior to a regulatory pathway design from Congress;
- Non-inferiority trials – a growing issue for drug makers and which could influence reimbursement decisions;
- Best Practices for Conducting Pharmacovigilance Studies Using Electronic Healthcare Data – particularly with the potential for huge investment by the Administration in Health IT, this is particularly timely.
There are many others of interesting, including ones on proper labeling and naming and on Dear Doctor letters. Check out the list.