Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information.

Bibliographic Details
Corporate Authors:	Center for Biologics Evaluation and Research (U.S.) Center for Drug Evaluation and Research (U.S.) Center for Veterinary Medicine (U.S.)
Language:	English
Published:	Rockville, MD : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003]
Subjects:	Medical protocols > United States. Drug approval > United States. Veterinary drugs.
Online Access:	Connect to online resource - All users (Federal Depository Library Program Persistant URL)
Physical Description:	1 online resource (16 pages)
Variant Title:	Comparability protocols, chemistry, manufacturing, and controls information.
Format:	Government Document Electronic eBook

Similar Items

Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.
Published: (2010)

Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.
Published: (2008)

Guidance for industry : changes to an approved NDA or ANDA.
Published: (2004)

Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.
Published: (2001)

Guidance for industry : changes to an approved NDA or ANDA, questions and answers.
Published: (2001)

Guidance for industry : variations in drug products that may be included in a single ANDA.
Published: (1998)

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Published: (2004)

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

Guidance for industry : NDA's : impurities in drug substances.
Published: (2000)

Guidance for industry : accelerated approval products, submission of promotional materials.
Published: (1999)

Guidance for industry : referencing discontinued labeling for listed drugs in abbreviated new drug applications.
Published: (2000)

Guidance for industry : M4, organization of the CTD.
Published: (2001)

Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
Published: (2003)

Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).
Published: (2008)

Guidance for industry : ANDAs, impurities in drug products.
Published: (2005)

Guidance for industry : ANDAs, impurities in drug substances.
Published: (2009)

Guidance for industry : revising and ANDA labeling following revision of the RLD labeling.
Published: (2000)

Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
Published: (2001)

Guidance for industry : qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.
Published: (1999)

Guidance for industry : pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance.
Published: (2004)

Guidance for industry : classifying resubmissions in response to action letters.
Published: (1998)

Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
Published: (2001)

Guidance for industry : alternate source of the active pharmaceutical ingredient in pending ANDAs.
Published: (2000)

Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval.
Published: (2007)

Guidance for industry for the submission documentation for sterilization process validation in applications for human and veterinary drug products.
Published: (1994)

Guidance for industry : 180-day exclusivity when multiple ANDAs are submitted on the same day.
Published: (2003)

Guidance for industry : botanical drug products.
Published: (2004)

Guidance for industry : PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection.
Published: (2000)

Guidance for industry : formal dispute resolution, appeals above the division level.
Published: (2000)

Guidance for industry : M2, eCTD specification, questions & answers and change requests.
Published: (2005)

Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
Published: (2003)

Guidance for industry and FDA staff : how to write a request for designation (RFD).
Published: (2005)

Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products.
Published: (1997)

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

Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).
Published: (2008)

Guidance for industry : environmental assessment of human drug and biologics applications.
Published: (1998)

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

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

Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances.
Published: (1987)

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