In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management.  Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.”  The guidance covers the general quality risk management process but discusses the roles and responsibilities...Read More

June 17, 2020 Excerpts from a warning letter of interest to software professionals: “During our inspection, our investigators observed specific deviations including, but not limited to, the following… 3. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of...Read More

This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is,...Read More

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital...Read More

For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  Read More

The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures ActRead More

/docs/FDADrug-25591_Data-Integrity.pdfRead More

http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htmRead More

/docs/FDA-DraftProcessValidationGiuidance111808.pdfRead More

/docs/FDA-PATPresentationwatts_3_2005.pdfRead More

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdfRead More

/docs/barcodelabelrule0304.pdfRead More

/docs/FDATraining-Inspectionofcomputersyschapter22c.pdfRead More

/docs/21CFR211-68.pdfRead More

http://www.fda.gov/cder/guidance/4286fnl.pdfRead More

http://www.fda.gov/cder/regulatory/ersr/FDARegional/ectd.htmRead More

http://www.fda.gov/cder/guidance/4252fnl.pdfRead More

/docs/7356-002-Draft.PDFRead More

/docs/ICH-CDER-API-GMPguide.pdfRead More

http://www.fda.gov/cder/dmpq/freshair.htmRead More

/docs/ElectronicNDAprocessing.pdfRead More

/Docs/ICH-GCPs959fnl.pdfRead More

/Docs/7132a-425-400.PDFRead More

/Docs/7132a-425-100.pdfRead More

/Docs/7132a-425-200.PDFRead More

/Docs/7132a-425-500.PDFRead More

/Docs/7132a-425-300.PDFRead More

/Docs/FDAdrugswguidanceFeb1983.pdfRead More