Cover Image

Guidance for industry : providing regulatory submissions in electronic format, receipt date.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2007]
Subjects:	Electronic filing systems > Government policy > United States. Drugs > Testing > Government policy > United States. Biologicals > Evaluation > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS113402

Similar Items

Guidance for industry : providing regulatory submissions in electronic format, drug establishment registration and drug listing.
Published: (2009)

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 : providing regulatory submissions in electronic format, general considerations.
Published: (1999)

Guidance for industry : providing regulatory submissions in electronic format, general considerations.
Published: (2003)

Guidance for industry : providing regulatory submissions in electronic format, content of labeling.
Published: (2005)

Guidance for industry : providing regulatory submissions in electronic format, prescription drug advertising and promotional labeling.
Published: (2001)

Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.
Published: (2001)

Guidance for industry : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs).
Published: (2002)

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

Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.
Published: (2008)

Guidance for industry : clinical studies section of labeling for human prescription drug and biological products, content and format.
Published: (2006)

Guidance for industry : handling and retention of BA and BE testing samples.
Published: (2004)

Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Published: (1995)

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

Guidance for industry for the submission of chemistry, manufacturing and controls and establishment description information for human blood and blood components intended for transfusion or for further manufacture and for the completion of the form FDA 356h "Application to market a new drug, biologic or an antibiotic drug for human use".
Published: (1999)

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 : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.
Published: (1995)

Guidance for industry : development and use of risk minimization action plans.
Published: (2005)

Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications.
Published: (2009)

Guidance for industry : clinical lactation studies; study design, data analysis, and recommendations for labeling.
Published: (2005)

Guidance for industry : Q1B photostability testing of new drug substances and products.
Published: (1996)

Guidance for industry : potassium chloride modified-release tablets and capsules, in vivo bioequivalence and in vitro dissolution testing.
Published: (2005)

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

Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers.
Published: (2008)

Guidance for industry and FDA staff : early development considerations for innovative combination products.
Published: (2006)

Guidance for industry : PAC-ATLS : postapproval changes, analytical testing laboratory sites.
Published: (1998)

Guidance for industry : format and content for the CMC section of an annual report.
Published: (1994)

Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.
Published: (2004)

Guidance for industry : Q3A impurities in new drug substances.
Published: (2008)

Guidance for industry : Q3B(R2) impurities in new drug products.
Published: (2006)

Guidance for industry : part 11, electronic records : electronic signatures--scope and application.
Published: (2003)

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

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

Guidance for industry : street drug alternatives.
Published: (2000)

Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit sampling and assessment.
Published: (2003)

Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit sampling and assessment.
Published: (2003)

Guidance for industry : formal meetings between the FDA and sponsors or applicants.
Published: (2009)

Guidance for industry : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information.
Published: (2007)

Guidance for industry : expiration dating and stability testing of solid oral dosage form drugs containing iron.
Published: (1997)

Guidance for industry. electronic signatures, scope and application.
Published: (2003)