Improving Regulatory Transparency for New Medical Therapies Act : report (to accompany H.R. 4299) (including cost estimate of the Congressional Budget Office).

Sunscreen Innovation Act : report (to accompany H.R. 4250) (including cost estimate of the Congressional Budget Office).
Published: (2014)

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)

Improving predictability and transparency in DEA and FDA regulation : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, April 7, 2014.
Published: (2015)

Guidebook for drug regulatory submissions /
by: Weinberg, Sandy, 1950-
Published: (2009)

Purple Book Continuity Act of 2019 : report (to accompany H.R. 1520) (including cost estimate of the Congressional Budget Office).
Published: (2019)

Improving Treatment for Pregnant and Postpartum Women Act of 2016 : report (to accompany H.R. 3691) (including cost estimate of the Congressional Budget Office).
Published: (2016)

Medical writing in drug development : a practical guide for pharmaceutical research /
by: Bonk, Robert J.
Published: (1998)

The pharmaceutical regulatory process /
Published: (2005)

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

Methamphetamine Education, Treatment, and Hope Act of 2010 : report (to accompany H.R. 2818) (including cost estimate of the Congressional Budget Office).
Published: (2010)

Ensuring Patient Access and Effective Drug Enforcement Act of 2014 : report (to accompany H.R. 4709) (including cost estimate of the Congressional Budget Office).
Published: (2014)

Ensuring Patient Access and Effective Drug Enforcement Act of 2015 : report (to accompany H.R. 471) (including cost estimate of the Congressional Budget Office).
Published: (2015)

Opioid Prescription Verification Act of 2021 : report (to accompany H.R. 2355) (including cost estimate of the Congressional Budget Office).
Published: (2021)

Ensuring Compliance against Drug Diversion Act of 2019 : report (to accompany H.R. 4812) (including cost estimate of the Congressional Budget Office).
Published: (2020)

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

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

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

Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 : report together with dissenting views (to accompany H.R. 2851) (including cost estimate of the Congressional Budget Office).
Published: (2018)

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

Examining Opioid Treatment Infrastructure Act of 2016 : report (to accompany H.R. 4982) (including cost estimate of the Congressional Budget Office).
Published: (2016)

Debarment Enforcement of Bad Actor Registrants Act of 2020 : report (to accompany H.R. 4806) (including cost estimate of the Congressional Budget Office).
Published: (2020)

Reducing Unused Medications Act of 2016 : report (to accompany H.R. 4599).
Published: (2016)

Off-label prescribing : justifying unapproved medicine /
by: Cavalla, David
Published: (2015)

Drugs : from discovery to approval /
by: Ng, Rick
Published: (2004)

Orange Book Transparency Act of 2019 : report (to accompany H.R. 1503) (including cost estimate of the Congressional Budget Office).
Published: (2019)

Animal Generic Drug User Fee Act of 2008 : report (to accompany H.R. 6433) (including cost estimate of the Congressional Budget Office).
Published: (2008)

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)

Medicare Clear Health Options in Care for Enrollees Act Of 2018 : report (to accompany H.R. 5686) (including cost estimate of the Congressional Budget Office).
Published: (2018)

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

Coordinated Response through Interagency Strategy and Information Sharing Act : report (to accompany H.R. 5925) (including cost estimate of the Congressional Budget Office).
Published: (2018)

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

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

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

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