Guidance for industry : granularity document : annex to M4, organization of the CTD.

Guidance for industry : M4E, the CTD, efficacy.
Published: (2001)

Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers.
Published: (2005)

Guidance for industry : M4S, the CTD, safety appendices.
Published: (2001)

Guidance for industry : E2BM data elements for transmission of individual case safety reports.
Published: (2002)

Guidance for industry : M4Q, the CTD, quality.
Published: (2001)

Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.
Published: (2008)

Guidance for industry : how to comply with the Pediatric Research Equity Act.
Published: (2005)

Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2009)

Guidance for FDA staff and industry : marketed unapproved drugs, compliance policy guide.
Published: (2006)

Improving public health : promting safe and effective drug use.
Published: (2003)

Manual del Centro para la Evaluacion e Investigacion de Farmacos.
Published: (2001)

Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.
Published: (2005)

Management of information technology contracts at the Food and Drug Administration's Center for Drug Evaluation and Research.
Published: (2009)

Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.
Published: (2004)

Guide to clinical trials /
by: Spilker, Bert
Published: (1991)

A first-order characterization of clinical trials /
by: Hopwood, Marsha
Published: (1980)

Guidance for industry : bar code label requirements, questions and answers.
Published: (2006)

Reviewer guidance : conducting a clinical safety review of a new product application and preparing a report on the review.
Published: (2005)

Guidance for industry : preparation of IDEs and INDs for products intended to repair or replace knee cartilage.
Published: (2007)

Mejorando la salud pública : fomentando la venta y el uso de drogas efectivas.
Published: (2003)

Raising hell : how the Center for Investigative Reporting gets the story /
Published: (1983)

The CDER reference guide.

Lessons from a horse named Jim : a clinical trials manual from the Duke Clinical Research Institute /
by: Liu, Margaret B.

Handbook of clinical drug research /
Published: (1986)

Guidance for industry : E6 good clinical practice, consolidated guidance.
Published: (1996)

Annual report.
Published: (2004)

Clinical pharmacology in drug development.
Published: (2012)

Planning pharmaceutical clinical trials : basic statistical principles /
by: Wooding, William M.
Published: (1994)

Annual report of clinical research activities /

Annual report of clinical research activities /
Published: (1999)

Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
Published: (2008)

Guidance for industry : E 10 choice of control group and related issues in clinical trials.
Published: (2001)

The development of a medicine /
by: Smith, R. B. (Richard Barry), 1940-
Published: (1985)

Cardiac safety of noncardiac drugs : practical guidelines for clinical research and drug development /
Published: (2005)

Guidance for industry : submitting and reviewing complete responses to clinical holds.
Published: (2000)

The Decision to initiate clinical trials of current medical practices /
Published: (1985)