Call Number (LC) Title Results
HE 20.4702:R 26/2/ Quick index to general subjects of interest related to drug regulation. 1
HE 20.4702:R 26/4 Guidance for industry providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications. 1
HE 20.4702:R 26/5 Guidance for industry providing regulatory submissions in electronic format, receipt date. 1
HE 20.4702:R 26/6 Guidance for industry providing regulatory submissions in electronic format, content of labeling. 1
HE 20.4702:R 26/7 Guidance for industry providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling. 1
HE 20.4702:R 26/8 Guidance for industry providing regulatory submissions in electronic format, general considerations. 1
HE 20.4702:R 26/995 Drug registration and listing instruction booklet. 1
HE 20.4702:R 26/996 Drug registration and listing instruction booklet. 1
HE 20.4702:R 26/998 Drug registration and listing instructions 1
HE 20.4702:R 29/DRAFT Reviewer guidance integration of study results to assess concerns about human reproductive and developmental toxicities. 1
HE 20.4702:R 31/2 Guidance for industry submitting and reviewing complete responses to clinical holds. 1
HE 20.4702:R 31/3 Guidance for industry classifying resubmissions in response to action letters. 1
HE 20.4702:R 31/REV.1 Guidance for industry fast track drug development programs, designation, development and application review. 1
HE 20.4702:R 44 Guidance for industry protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators. 1
HE 20.4702:R 49 Guidance for industry development and use of risk minimization action plans. 1
HE 20.4702:R 49/2 Guidance for industry premarketing risk assessment. 1
HE 20.4702:R 49/3/DRAFT Guidance for industry format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications. 1
HE 20.4702:R 49/4/DRAFT Guidance for industry brief summary : disclosing risk information in consumer-directed print advertisements. 1
HE 20.4702:R 49/5/DRAFT Guidance for industry presenting risk information in prescription drug and medical device promotion. 1
HE 20.4702:SA 1 Guidance for industry nonclinical studies for the safety evaluation of pharmaceutical excipients. 1