In this article, we will highlight some key sources of information for new clinical trials and regulatory updates, including ClinicalTrials.gov, the FDA's Center for Drug Evaluation and Research (CDER), the European Medicines Agency (EMA), the World Health Organization (WHO), PubMed, Regulatory Focus, and the Regulatory Affairs Professionals Society (RAPS).
By staying up-to-date with the latest developments in the industry, drug developers can ensure that they are well-informed and equipped to make informed decisions about drug development, patient care, and regulatory compliance.
ClinicalTrials.gov: This is a publicly accessible database of clinical trials conducted around the world. It is maintained by the National Library of Medicine and provides information on the purpose, design, and status of clinical trials, as well as contact information for the study organizers.
FDA's Center for Drug Evaluation and Research (CDER): The CDER is responsible for the regulation of drugs in the United States. Its website provides updates on drug approvals, labeling changes, and safety alerts, as well as guidance documents for drug developers.
European Medicines Agency (EMA): The EMA is the regulatory agency responsible for the evaluation and supervision of medicinal products in the European Union. Its website provides updates on drug approvals, labeling changes, and safety alerts, as well as guidance documents for drug developers.
World Health Organization (WHO): The WHO is responsible for the coordination of international health activities and the development of health policy. Its website provides updates on drug approvals, regulatory guidelines, and global health initiatives.
PubMed: This is a database of scientific publications maintained by the National Library of Medicine. It provides access to a wide range of research articles, including those related to clinical trials and regulatory updates.
Regulatory Focus: This is an online publication focused on regulatory affairs and drug development. It provides news and analysis on regulatory updates and trends, as well as insights from industry experts and regulatory agencies.
Regulatory Affairs Professionals Society (RAPS): RAPS is a global organization for regulatory professionals in the pharmaceutical, medical device, and biotech industries. Its website provides news and updates on regulatory developments, as well as resources for regulatory professionals.