FDA Modernization Act of 1995

FDA Modernization Act of 1995 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to add rapidly making decisions on the approval of drugs, devices, and biological products to the list of general powers of the Commissioner of Food and Drugs.

Allows a new drug or device to treat life-threatening or serious conditions to receive conditional approval on the basis of valid scientific evidence demonstrating a reasonable assurance of safety and effectiveness.

Deems a new drug or device application approved after 30 days unless the Secretary of Health and Human Services (or the Secretary, on the recommendation of a certified institutional review board) disapproves. Mandates use of the boards to approve Phase I clinical investigations. Regulates certification of boards and approval by boards of Phase I investigations. Authorizes the Secretary or a board to place an investigation on clinical hold. Considers board members and personnel of an institution under which a board was organized to be Government employees. Authorizes Phase I approval cost grants to boards.

Authorizes contracts with certified individuals and laboratories for any Food and Drug Administration function relating to the approval of drugs or devices. Provides for the certification.

Prohibits review for approval of a new drug, device, or biological product from including an environmental impact review under the Environmental Quality Improvement Act of 1970.

Modifies the definitions of "labeling" and "advertising" to allow additional information. Authorizes the Secretary to require that labeling or advertising include a statement by the Secretary if the information is scientifically insufficient, inaccurate, or misleading. Prohibits subjecting labeling or prescription drug advertising to approval prior to use or dissemination.

Deems new device or biological product applications approved within 45 days after an expert advisory panel recommends approval. Provides for such panels.

Mandates regulations regarding good manufacturing practices for drugs and biological products.

Revises the requirements that must be met to export food, drugs, devices, or cosmetics.

Amends the Public Health Service Act to provide for the regulation of biological products.

Amends the FDCA to provide for the exemption of certain class I and class II devices from requirements to report prior to their interstate commerce introduction.

Prohibits device approval delay because the person making such a report is in violation of good manufacturing practice requirements.