...name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 5. A statement of the methods, facilities, and controls...any clinical studies and experience with the drug as follows: a. Adequate Information about the preclinlcal Investigations, Including studies made on laboratory...

...controls used for the manufacturing, processing, and packing of the investigational drug are inadequate to establish and maintain appropriate standards of...significance to clinical investigations made with the drug; or (6) The plan for clinical investigations of the drugs described under section 10 of the "Notice...

...controls used for the manufacturing, processing, and packing of the investigational drug are inadequate to establish and maintain appropriate standards of...significance to clinical investigations made with the drug; or (6) The plan for clinical investigations of the drugs described under section 10 of the "Notice...

...of each supplier or processor, other than the undersigned, of each new-drug substance. "5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...

...of each supplier or processor, other than the undersigned, of each new-drug substance. "5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...

...address of each supplier or processor, other than the undersigned, of each new-drug substance. 5. A brief statement of the methods, facilities, and controls...identity, strength, quality, and purity as needed to give significance to clinical investigations made with the drug. If any of these operations are...

...composition of drug, Including reasonable variations that may be expected during the Investtgatlonal stage. 4. Description of source and preparation of...Information available to the sponsor derived from precllnlcal Investigations and any clinical studies and experience with the drug as follows : a. Adequate...

...of each new -drug substance. 5. A statement of the methods, facilities, and controls used for the ' drug to establish and maintain appropriate standards...A statement covering all information available to any clinical studies and experience with the drug as follows: a. Adequate information about the pieclinical...

...gatlonal étage. 4. Description of Bource and preparation of any new-drug substances used as component«. Including the name and address of each supplier or...Information available to the sponsor derived from precllnlcal Investigations and any clinical studies and experience with the drug as follows: a. A'if-quate...

...name and address of each supplier or processor, other than the sponsor, of each new-drug substance. 5. A statement of the methods, facilities, and controls...information available to the sponsor derived from preclinical investigations and any clinical studies and experience with the drug as follows: a. Adequate...