US aims to tighten rules on direct-to-consumer drug ads

Article Abstract:

The Democratic party-controlled Congress is planning to tighten the restrictions on direct-to-consumer (DTC) advertising, which might have a major impact of the U.S. biotech industry. The U.S. Food and Drug Administration has also recommended the Congress to pass a new Prescription Drug User Fee Act (PDUFA) that includes separate fees for DTC advertisements.

Government domestic functions, Advertising, Advertising and Related Services, Consumer Advertising, Health policy

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Uncertainty surrounds cancer vaccine review at FDA

Article Abstract:

Cancer experts believe that the U.S. Food and Drug Administration (FDA) should fine-tune the review criteria to emphasize that vaccine-treated cancer patients are living longer. The scientific community and regulatory committees should rethink about the design of clinical vaccine trials and approach to measuring the effectiveness of a cancer vaccine.

Product development, Science & research, Management dynamics, Research, Management, Company business management, United States. Food and Drug Administration, Cancer vaccines

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Walking the drug regulatory tightrope

Article Abstract:

The rapidly changing regulatory environment of the pharmaceutical industry is discussed.

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