Regulatory Guidance for Clinical Protocols and Clinical Labels

We can write the clinical supplies section for the clinical protocol, and we can provide regulatory guidance for:

R     The clinical drug supplies section of the clinical protocol

R     The clinical label text (US and international) for clinical studies.

The minimum requirements for US label text include the following: 

Ø      Study Protocol Number

Ø      Drug Name (as appropriate)

Ø      Dosage Form (as appropriate)

Ø      Drug Strength (as appropriate)

Ø      Quantity

Ø      Expiration Date/Retest Date (as appropriate)

Ø      Lot Number (as appropriate)

Ø      Subject Identification (as appropriate)

Ø      Directions for Use

Ø      Safety Instructions (as appropriate)

Ø      Storage Conditions

Ø      Caution Statement(s)

Ø      Sponsor’s Identification and Address

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