SEC. 526 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT [21 USC 360bb]. (a) (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare...

for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public

(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological products and antibiotics. This part sets forth the procedures and requirements for:

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

On 4 January 1983, President Ronald Reagan signed the ODA into law. Under the ODA drugs, vaccines, and diagnostic agents would qualify for orphan status if they were intended to treat a disease affecting less than 200,000 American citizens.

request for designation of the drug under section 526 of the Federal Food, Drug, and Cosmetic Act is made. (3) The term ‘‘medical food’’ means a food which is formu-lated to be consumed or administered enterally under the su-pervision of a physician and which is intended for the specific

Sep 30, 2014 · Following Special Forces Selection and the Qualification course, he served as Detachment Commander of ODA 526 and the OPS Officer for 1 st Battalion, 5 th SF Group during which he served in Desert SHIELD/STORM and in Somalia. He commanded A CO, 2 nd BN, 5 th SF Group and served as 2 nd BN XO.

The Orphan Drug Act (ODA) , first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed.

Following Selection and the Qualification course, his initial Special Forces assignments were as the Detachment Commander of ODA 526 and the Operations Officer for 1st Battalion, 5th Special Forces Group (Airborne) (5th SFG(A)) during which he served in SHIELD/STORM and in Somalia.

The Orphan Drug Act (ODA) was the result of patient advocacy and by many measures has been strikingly successful. However, approximately 95% of the more than 7,000 known rare diseases still have no US Food and Drug Administration–approved treatment.