Final answer:
The development of a new contraceptive method including the FDA approval process typically spans several years, incorporating extensive testing for safety and effectiveness in clinical trials before an NDA is submitted.
Step-by-step explanation:
The estimated time it takes to develop a new contraceptive method, factoring in the FDA approval process, is typically several years. The journey begins with significant laboratory data from animal trials, followed by the submission of an Investigational New Drug (IND) application to the FDA's Center for Drug Evaluation and Research (CDER). After a 30-day review period, clinical trials with human subjects may commence.
Throughout the clinical trials, researchers must collect and analyze data on the drug's effectiveness and safety, addressing any side effects observed. If the FDA concludes that the new contraceptive meets their standards for both safety and effectiveness, the developers then submit a New Drug Application (NDA) detailing the drug's manufacturing, packaging, monitoring, and administration protocols.
The complexities of this process also raise ethical questions regarding the speed at which new therapies should reach the market and ensuring adequate testing for their safety and effectiveness before they are widely available.