FDA's authority to ensure that drugs prescribed to children are safe and effective /

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

Challenges for the FDA : the future of drug safety : workshop summary /
Published: (2007)

FDA checkup : drug development and manufacturing challenges : hearing before the Subcommittee on Energy Policy, Health Care and Entitlements of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Thirteenth Congress, first session, December 12, 2013.
Published: (2014)

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

Access to unapproved drugs : FDA policies on compassionate use and emergency use authorization /
by: Thaul, Susan
Published: (2018)

FDA's drug review process and the package label : strategies for writing successful FDA submissions /
by: Brody, Tom
Published: (2017)

FDA and the drug development process : how the agency ensures that drugs are safe and effective.
Published: (2002)

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

FDA fast track and priority review programs /
by: Thaul, Susan
Published: (2018)

Drug manufacturing : FDA should fully assess its efforts to encourage innovation : report to congressional committees /
Published: (2023)

FDA's regulation of the new drug Versed : hearings before a subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, second session, May 5 and 10, 1988.
Published: (1988)

Center for Drug Evaluation and Research update.

The administration's FDA reforms and reduced biopharmaceutical drug prices /
Published: (2018)

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

FDA drug approval : review time has decreased in recent years : report to congressional requesters.
Published: (1995)

FDA user fees 2012 : how innovation helps patients and jobs : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, second session, April 18, 2012.
Published: (2013)

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

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

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

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)

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

FDA-approved bargain drugs : generic products must meet high standards.
Published: (2003)

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

The future of drug safety : promoting and protecting the health of the public /
Published: (2007)

Ensuring drug safety : where do we go from here? : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining the Food and Drug Administration's process of ensuring drug safety, March 3, 2005.
Published: (2005)

Ensuring drug safety : where do we go from here? : hearing before the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining the Food and Drug Administration's process of ensuring drug safety, March 3, 2005.
Published: (2005)

CDER ... report to the nation : improving public health through human drugs /
Published: (1998)

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

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

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)

Pediatric drug research : Food and Drug Administration should more efficiently monitor inclusion of minority children.
Published: (2003)

Making better drugs for children with cancer /
Published: (2005)

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

Reviewing FDA's implementation of FDASIA : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, first session, November 15, 2013.
Published: (2014)

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)