@drsermedmezher: Thalidomide is Making a Comeback #History. The thalidomide disaster of the late 1950s and early 1960s, which resulted in thousands of birth defects due to the drug's use during pregnancy, profoundly impacted pharmaceutical regulations worldwide. In response to this tragedy, numerous countries overhauled their drug approval and monitoring processes to enhance drug safety and protect public health. Stricter Drug Approval Processes: Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), implemented more rigorous pre-market testing requirements. These include mandatory animal studies and more comprehensive clinical trials to evaluate the safety and efficacy of new drugs before they can be approved for public use. Enhanced Pharmacovigilance: Post-marketing surveillance systems were strengthened to monitor adverse drug reactions and other safety issues once a drug is on the market. This allows for the timely detection and management of potential risks associated with pharmaceutical products. Informed Consent and Transparency: Regulations were introduced to ensure that patients are better informed about the potential risks and benefits of medications. This includes clearer labeling, more detailed patient information leaflets, and requirements for obtaining informed consent from participants in clinical trials. #thalidomide #pregnancy #women

Dr Sermed Mezher MBChB MRes

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Saturday 25 May 2024 13:28:40 GMT