Protocol assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.

Target product profile (TPP)

A TPP is a format for a summary of a drug development program described in terms of labeling concepts.

New Drug Application (NDA)

A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.

Scientific Advice (SA)

Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medi

Food and Drug Administration (FDA or USFDA)

The FDA is a Federal agency within US Department of Health and Human Services, which is the primary regulating body of Food and Drug substances in the USA.

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action

Adaptive Pathways

Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients, with the need to provide adequate evolving information on benefits and

CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diag