Introduction to the Pharmaceutical Regulatory Process

Asserting that regulatory agencies such as the US Food and Drug Administration (FDA) and the pharmaceutical industry are constantly striving to improve the regulatory process through legislation and revised regulations and guidances, international regulatory business consultant Berry assembles views from US companies, lawyers, and a few representative of the FDA. Among their topics are the approval process for new drugs before and after 1962, the generic drug approval process after the 1984 Hatch-Waxman reform, the influence of the Prescription Drug User Fee Act on the approval process, active pharmaceutical ingredients, current good manufacturing practice and the drug approval process, ways and means to registering foreign drugs in the US, and the impact of government regulations on marketing and advertising.