Regulatory agencies interaction

It is possible to interact with the various regulatory agencies (particularly the FDA) when peculiarities of science or technology leave one with an unclear understanding of what testing is required. It is best if such discussions directly involve the scientists who understand the problems, and it is essential that the scientists at the FDA be approached with a course of action (along with its rationale) that has been proposed to the agency in advance. 

Today s pharmaceuticals are not the routine antibiotics of yesteryear. FDA is now approving more sophisticated and complicated chemical entities with complex risk/benefit profiles. Some products currently on the market, such as Accutane (isotretinoin, Hoffmann-LaRoche, Nutley NJ, U.S.A.), might not be there without patient information accompanying the product. Patients must understand the risks and limitations of medical products so they can use them properly. By necessity, patient education will become more critical as regulatory agencies approve more drugs with complicated regimens and interaction profiles. 

Understand the interaction between regulatory agencies and pharmaceutical companies... 

The relevance and importance of the regulatory environment cannot be overemphasized. This overview of the roles and responsibilities of both the sponsor and the regulatory agency serves to illustrate the interaction between the two, both before and after a drug is approved for marketing. As well as being experts on... 

The case-by-case approach that is needed for the effective preclinical development of biopharmaceuticals requires close collaboration and agreement between the sponsor and the regulatory agency at all stages of development. In the United States, such collaboration and scientific advice is often achieved through interaction with the FDA at pre-IND, end of phase 2, or pre-NDA meetings with the Agency. 

The major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

Erythromycin may cause increases in the semm levels of simvastatin. The CSM has advised that this should not be co-prescribed with simvastatin. In the first instance the pharmacist should check local policies for management of hospital acquired chest infections/pneumonia to ascertain first and second line choices. If erythromycin or any macrolide cannot be avoided then a practical way forward may be to avoid taking any dose of simvastatin for the duration of the course of macrolide. In addition a recent Dmg Safety Update from the Medicines and Healthcare Products Regulatory Agency (MHRA, 2008) on statins has highlighted statin dmg interactions and the appropriate actions to take. 

The final responsibility of the clinical project team is to ensure that all the research studies are appropriately documented in technical reports or scientific publications, and to compile this information, along with the necessary summaries, into an NDA or BLA submission. After submission, the project team interacts with the regulatory agency and provides answers to any questions. If requested, the project team designs and conducts the necessary research studies to support the submission. Once the NDA or BLA has been approved, the final responsibility of the clinical development team is to coordinate the launch of the new therapeutic agent. 

The physician s involvement in clinical research does not end with the completion of the clinical study. Medical reports, clinical study reports, and sections of NDAs must be written. Interactions with regulatory agencies that require the physician s input may occur frequently. Physicians in clinical research may also be called upon to promote new drugs in a scientific environment by organizing symposia and workshops and by reviewing journal advertisements and promotional material for medical validity and accuracy. 

Following reports about the potential for herb-drug interactions, many national regulatory agencies issued warnings about the use of St. John s wort and its safety was reviewed (21,22). 

The principal actors in medical policy and politics—government regulatory agencies, pharmaceutical companies, the medical profession, and disease-based organizations—interact in distinct political and medical settings. The chapters that follow describe the impact of American and German therapeutic cultures... 

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