Public Meeting - Radioactive Drugs for Certain Research Uses

November 16, 2004

Advisors and Consultants Conference Room 1066
5630 Fishers Lane, Rockville, MD 20857

The Food and Drug Administration is holding a public meeting to discuss the use of radioactive drugs for basic research purposes under the Radioactive Drug Research Committee (RDRC) program described in the Code of Federal Regulations, Title 21, Part 361.

Federal Register Notice [TXT] [PDF]

The meeting will be held on November 16, 2004, 8:00 am to 4:30 pm, at the CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD 20857.

No registration is required to attend the meeting. Seating is limited to 120 and will be on a first-come, first-served basis.

Meeting Objectives and Questions

Meeting Agenda (Final) (updated 11/12/2004)

Federal Regulations

• 21 CFR 361.1 Sec. 361.1 Radioactive Drugs for Certain Research Uses
• 21 CFR 312 Investigational New Drug Application
• 21 CFR 50 Subpart D Additional Safeguards for Children in Clinical Investigations

Security

Please allow time during your arrival to the meeting for security procedures (i.e. metal detector scanning and photo identification check).

Parking

Limited parking is available in front of the 5630 Fishers Lane Building. A public parking lot is located on Fishers Lane across from the Parklawn Building.

Directions:

From the Capital Beltway (Silver Spring)

• Take I-270 N towards Frederick
• Take MD-187 N/Old Georgetown Road
• Turn left onto Rockville Pike/MD-355 N
• Turn right onto Twinbrook Parkway
• Turn right onto Fishers Lane
• Building is on right.

From the Capital Beltway (Virginia)

• Take I-270 towards Rockville/Frederick
• Merge onto I-270 Spur N I-270 Spur N becomes I-270 North
• Take I-270 Local north towards Montrose Road
• Take Montrose Road East
• Turn left on Rockville Pike/MD-355 N
• Turn right onto Twinbrook Parkway
• Turn right onto Fishers Lane
• Building is on right.

Restaurants

A flyer listing eating establishments within walking distance of the 5630 Fishers Lane Building will be available at the meeting.

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Date created: October 5, 2004, updated November 12, 2004

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