Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances

Saved in:

Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.)
Format:	Government Document Online Book
Language:	English
Published:	Rockville, Md. : Center for Drug Evaluation and Research, Food and Drug Administration, Dept. of Health and Human Services, [1987]
Subjects:	Drug approval > Documentation > United States.
Access:	ONLINE VERSION How to Borrow from Another Library Search for the book on EZBorrow. EZBorrow is the easiest and fastest way to get the book you want (ebooks unavailable). Use ILLiad for articles and chapter scans. Make an ILLIAD request. If your book is not available on EZBorrow, you can request it through ILLiad (ebooks unavailable). You can also use ILLiad to request chapter scans and articles.
Tags:	Add Tag No Tags, Be the first to tag this record!

Similar Items

Guideline for submitting documentation for the manufacture of and controls for drug products
Published: (1987)

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

Perspectives of drug manufacturers : investigational new drug and new drug applications.
Published: (1990)

Guidelines for submitting samples and analytical data for methods validation
Published: (1987)

Perspectives of drug manufacturers : abbreviated new drug applications.
Published: (1990)

Dose-response information to support drug registration.
Published: (1994)

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

New drug approval FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate.
Published: (2009)

FDA's review process for new drug applications : a management review.
Published: (2003)

Center for Drug Evaluation and Research update

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

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

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

European Union : authorization of drugs already approved in the United States /
by: Papademetriou, Theresa
Published: (2015)

Food and Drug Amendments of 2022 : report of the Committee on Energy and Commerce (to accompany H.R. 7667).
Published: (2022)

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

New drug development science, business, regulatory, and intellectual property issues cited as hampering drug development efforts : report to conggressional requesters.
Published: (2006)

New drug approval FDA's consideration of evidence from certain clinical trials : report to congressional requesters.
Published: (2010)

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

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

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

Drug pricing and the law : regulatory exclusivities /
by: Ward, Erin H.
Published: (2019)

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

An Act to Amend the Federal Food, Drug, and Cosmetic Act with Respect to the Scope of New Chemical Exclusivity.
Published: (2021)

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

E 16 genomic biomarkers related to drug response context, structure, and format of qualification submissions.
Published: (2009)

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

Animal drug user fee agreements : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Thirteenth Congress, first session, on examining animal drug user fee agreements, focusing on advancing animal health for the public health, February 27, 2013.
Published: (2014)

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

Amending the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs : report (to accompany H.R. 1407) (including cost estimate of the Congressional Budget Office).
Published: (2013)

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

An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the Animal Drug User Fee Program, to Establish a Program of Fees Relating to Generic New Animal Drugs, to Make Certain Technical Corrections to the Food and Drug Administration Amendments Act of 2007, and for Other Purposes
Published: (2008)

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

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

Prescription drugs FDA has met most performance goals for reviewing applications : report to congressional requesters.
Published: (2012)

Intelligent drug development : trials and errors in clinical research /
by: Tansey, Michael
Published: (2020)

Intelligent drug development : trials and errors in clinical research /
by: Tansey, Michael
Published: (2014)