Innovation, Regulation, and the FDA  

Oleh:

Hamburg, Margaret A.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 363 no. 23 (Dec. 2010), page 2228-2232.
Topik: Food and Drugs Act

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2010.01 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

Lihat Detail Induk

Isi artikel

More than a century ago, Congress passed the 1906 Pure Food and Drugs Act, which transformed a small scientific bureau in the basement of the Department of Agriculture building into a federal regulatory agency charged with protecting the nation's supply of food and drugs. This regulatory agency would eventually become the Food and Drug Administration (FDA). Since the agency was founded, advances in science and medicine have transformed our understanding and treatment of many diseases. And the FDA has evolved in response to our changing world, taking on new responsibilities and playing a critical role in promoting and protecting the health of the public. Despite the essential and unique contributions of the FDA, the agency's regulatory role is periodically questioned, including in recent litigation that challenges, on First Amendment grounds, the permissible scope of the FDA's regulatory capacity and its ability to assess and ensure the safety and effectiveness of medications, vaccines, and medical devices. With history and these lawsuits as a backdrop, I offer a perspective on the important role that the FDA has played — and must continue to play — in protecting health and safety and facilitating the interplay among innovation, evidence, and medicine.

Opini Anda

Klik untuk menuliskan opini Anda tentang koleksi ini!

Kembali