https://www.sidley.com/en/insights/newsupdates/2025/07/us-fda-publishes-final-guidance-for-remote-regulatory-assessments?utm_source=chatgpt.com
ufdafinalremoteassessments
https://www.usf.edu/research-innovation/research-support/research-integrity-compliance/quality-assurance-improvement/fda-guidance-documents.aspx
FDA Guidance Documents in QA/QI in Research Integrity & Compliance in Research & Innovation at the University of South Florida.
fda guidanceresearch integritydocumentsqaqi
https://www.raps.org/news-and-articles/news-articles/2021/11/fda-issues-draft-guidance-for-device-software-in-p
FDA has updated the documentation required for sponsors with devices that include software that meets the above specifications. The agency will now consider...
draft guidancedevice softwarefdaissuespremarket
https://www.raps.org/news-and-articles/news-articles/2020/1/fda-finalizes-2018-guidance-on-use-of-minimal-resi
The US Food and Drug Administration (FDA) on Friday finalized guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in...
minimal residual diseasefdaguidanceuse
https://www.denver7.com/lifestyle/health/doctor-gives-guidance-on-who-should-get-covid-19-vaccine-amid-new-fda-rules-changing-access-to-shots
Denver7 is working to get you the latest guidance on who is recommended to get a COVID-19 vaccine this year as Colorado responds to new FDA rules that change...
doctorguidancecovidvaccineamid
https://www.fda.gov/news-events/press-announcements/fda-updates-guidance-further-empower-companies-address-spread-misinformation
To help ensure the public has access to accurate, up-to-date, science-based information about FDA-regulated medical products, the FDA has updated its...
fda updatesguidanceempowercompaniesaddress
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-dura-substitute-devices-guidance-industry
Provides a summary of the information to include in a premarket notification (510(k)) submission for a dura substitute.
guidance documentdurasubstitutedevicesindustry
https://www.techtarget.com/pharmalifesciences/news/366606400/FDA-Provides-Guidance-for-Preventing-Contamination-in-Tattoo-Ink
Following a previous safety alert, the FDA provided draft guidance for preventing and reducing microbial contamination in the tattoo ink in a recent press...
tattoo inkfdaprovidesguidancepreventing
https://www.ansi.org/standards-news/all-news/2022/08/8-22-22-ansi-covid-19-news-cdc-streamlines-guidance-and-more
The ANSI Federation and standardization community are stepping up with guidance, resources, and initiatives to support public health and safety and the...
ansicovidnewscdcstreamlines
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/contact-cooling-system-aesthetic-use-class-ii-special-controls-guidance-industry-and-fda-staff
This was developed as a special control guidance to support the classification of the contact cooling system for aesthetic use into class II (special controls).
cooling systemclass iiaestheticusespecial
https://www.prnewswire.com/news-releases/fda-issues-comprehensive-draft-guidance-for-developers-of-artificial-intelligence-enabled-medical-devices-302343044.html
/PRNewswire/ -- Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe...
draft guidanceartificial intelligencefdaissuescomprehensive
https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/chemical-metals-natural-toxins-pesticides-guidance-documents-regulations
A list of guidance and regulations related to chemicals and pesticides
guidance documentschemicalmetalsnaturaltoxins
https://www.nextgov.com/cybersecurity/2016/04/fdas-cyber-guidance-gets-key-congressmans-support/220669/
Rep. Jim Langevin (D-R.I.) is backing the Food and Drug Administration's proposed cybersecurity guidance for medical device manufacturers.
fdacyberguidancegetskey
https://www.raps.org/news-and-articles/news-articles/2016/10/Developing-the-Next-Female-Viagra-FDA-Offers-Draf
The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened...
female viagradraft guidancedevelopingnextfda
https://www.dochub.com/fillable-form/266776-fda-industry-drug
Edit, sign, and share fda industry drug online. No need to install software, just go to DocHub, and sign up instantly and for free.
fda guidanceindustryfillsignonline
https://www.eastidahonews.com/2015/03/fda-issues-updated-guidance-for-reusable-devices-linked-to-superbugs/
ChrisPole/iStock/Thinkstock(NEW YORK) -- The U.S. Food and Drug Administration issued final guidance on Thursday on the reuse of medical devices and the...
fdaissuesupdatedguidancereusable
https://www.raps.org/news-and-articles/news-articles/2020/12/FDA-finalizes-guidance-on-complex-innovative-trial
The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID)...
innovative trialsfdaguidancecomplexdesigns
https://www.fda.gov/food/hfp-constituent-updates/fda-issues-draft-guidance-food-contact-substances-use-infant-formula-and-human-milk
The U.S. Food and Drug Administration has issued draft guidance to provide additional information on how to prepare Food Contact Notifications (FCNs) for food...
draft guidancefdaissuesfoodsubstances
https://www.fda.gov/food/hfp-constituent-updates/fda-releases-draft-guidance-ndi-enforcement-discretion
FDA made available for public comment a draft guidance on late submissions of new dietary ingredient (NDI) notifications.
draft guidanceenforcement discretionfdareleasesndi
https://www.raps.org/news-and-articles/news-articles/2022/1/fda-finalizes-guidance-on-premarket-review-of-comb
The final guidance@defines combination products, the coordination between the agency and sponsors, and makes recommendations on how to determine the types of...
combination productsfdaguidancepremarketreview
https://www.raps.org/news-and-articles/news-articles/2019/5/interchangeable-biosimilars-fda-finalizes-guidanc
The US Food and Drug Administration (FDA) on Friday finalized a long-awaited guidance spelling out how biosimilars can achieve an interchangeable status, which...
updatedinterchangeablebiosimilarsfdaguidance
https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-tattoo-inks?utm_medium=email&utm_source=govdelivery
FDA issued a draft guidance to tattoo ink manufacturers and distributors outlining steps they can take to help reduce microbial contamination in tattoo inks.
draft guidancetattoo inksfdaissues
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-control-listeria-monocytogenes-ready-eat-foods?utm_source=chatgpt.com
This guidance is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or...
draft guidanceindustry controllisteria monocytogenesready
https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-tattoo-inks
FDA issued a draft guidance to tattoo ink manufacturers and distributors outlining steps they can take to help reduce microbial contamination in tattoo inks.
draft guidancetattoo inksfdaissues
https://www.fda.gov/drugs/guidances-drugs/guidance-recap-podcast-master-protocols-drug-and-biological-product-development
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development
guidancerecappodcastmasterprotocols
https://www.process.st/templates/fda-guidance-sterilization-process-validation/
Identify product to be sterilized In this task, you need to identify the specific product that will undergo the sterilization process. This is important...
fda guidanceprocess validationsterilizationstreet
https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/egg-guidance-regulation-and-other-information
Frequently requested links for industry and consumer on eggs
eggguidanceregulationinformationfda
https://www.raps.org/news-and-articles/news-articles/2026/1/fda-drafts-guidance-on-cuffless-blood-pressure-mea
The US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) has issued a draft guidance to assist manufacturers in submitting...
blood pressuremeasuring devicesfdadraftsguidance
https://www.fda.gov/food/hfp-constituent-updates/fda-withdraws-guidance-industry-enforcement-approach-human-food-chlorpyrifos-residues
Food and Drug Administration released a guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with...
fdawithdrawsguidanceindustryenforcement
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements
Guidance and regulatory information on Food and Dietary Supplements; includes guidance for industry as well as manufacturing processes, food facility...
dietary supplementsguidanceregulationfoodfda
https://www.fiercebiotech.com/cro/fda-issues-draft-guidance-help-industry-conduct-global-cancer-clinical-trials
Once finalized, the guidance will provide recommendations for how industry can use data from global trials to support FDA approval in the U.S.
cancer clinical trialsdraft guidancefdaissuesglobal
https://www.raps.org/news-and-articles/news-articles/2018/7/single-enzyme-defects-fda-drafts-guidance-to-help
The US Food and Drug Administration (FDA) on Thursday released draft guidance to help sponsors understand the evidence necessary to demonstrate the...
singleenzymedefectsfdadrafts
https://www.fda.gov/food/importing-food-products-united-states/factsheet-final-guidance-industry-fdas-voluntary-qualified-importer-program-vqip?source=govdelivery
Factsheet on the Final Guidance for Industry for FDA's Voluntary Qualified Importer Program (VQIP)
factsheetfinalguidanceindustryfda
https://www.ajmc.com/view/fda-guidance-to-remove-one-of-the-largest-barriers-to-biosimilar-development
The FDA announced draft guidance to remove clinical efficacy studies for biosimilars and also issued the position that all biosimilars in the US should be...
fda guidanceremoveonelargestbarriers
https://www.raps.org/news-and-articles/news-articles/2024/7/fda-guidance-addresses-developing-treatments-for-p
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis (UC)...
fda guidanceaddressesdevelopingtreatmentspediatric
https://www.fool.com/investing/2020/03/19/fda-clinical-trial-guidance-covid-outbreak-disrupt.aspx
Efforts to stem the coronavirus outbreak are liable to disrupt the protocols of a lot of drug trials.
clinical trialsfdaissuesguidancecovid
https://www.prnewswire.com/news-releases/allos-pharma-inc-receives-fda-guidance-for-the-design-of-a-phase-3-trial-to-support-a-new-drug-application-for-treatment-of-fragile-x-syndrome-301832340.html
/PRNewswire/ -- Allos Pharma Inc. ("Allos"), a biopharmaceutical company specializing in the development of treatments for rare neurological disorders,...
fda guidanceallospharmaincreceives
https://www.fda.gov/drugs/guidance-compliance-regulatory-information
Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including nicotine-containing products,...
regulatory informationguidancecompliancefda
https://www.oliverwyman.com/our-expertise/perspectives/health/2023/november/fda-guidance-may-jumpstart-digital-therapeutics-market.html
Emerging clinical evidence shows the benefits of prescription digital therapeutics. The CEO of Click Therapeutics assesses where the market is heading.
fda guidancedigital therapeuticsmayjumpstartmarket
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555880-guidance-levels-radionuclides-domestic-and-imported-foods
The purpose of this document is to present guidance levels for radionuclide activity concentration, called derived intervention levels (DILs).
guidance levelscpgsecradionuclidesdomestic
https://www.drugwatch.com/news/2020/10/06/fda-issues-guidance-control-ndma-zantac-other-drugs/
The FDA has issued guidance for drugmakers on how to detect and prevent potential cancer-causing nitrosamine contamination in drugs.
fdaissuesguidancecontrolndma
https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/dietary-supplements-guidance-documents-regulatory-information
FDA issues guidance documents containing nonbinding recommendations to help industry understand and comply with all regulations.
dietary supplementsguidance documentsregulatory informationfda
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents
Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes.
cross cuttingguidance documentsfda
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/notice-use-united-states-food-drug-administration-guidance-materials-support.html
TThis notice is to remind manufacturers of their obligations under the Medical Devices Regulations when applying for medical device licences or Investigational...
united statesdrug administrationnoticeusefood
https://www.jdsupra.com/legalnews/fda-loosens-the-reins-new-ai-and-9383269/
On January 6, 2026, the US Food and Drug Administration (FDA) released updates to two guidance documents reflecting a move towards a more hands-off...
new aifdareinswearablesguidance
https://www.fda.gov/animal-veterinary/cvm-updates/fda-seeks-public-input-guidance-priority-zoonotic-animal-drug-designation
Today, the U.S. FDA issued draft guidance intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal...
public inputfdaseeksguidancepriority
https://www.raps.org/News-and-Articles/News-Articles/2025/1/FDA-finalizes-guidance-on-off-label-communications?utm_campaign=4037944-CAMPAIGN-RF%20Today%20-%20TEST&utm_medium=email&_hsenc=p2ANqtz-92IdvTVsvrziSSTVHiHLVJ2P6sPLV0O8rKy2yQ1Immq_Xvek01AGsnRiL2eJtsJNf2z-AUHSh_9XqJCSG5Bq-jmHP-zERW088QviSSAlYT6VrKR6U&_hsmi=341851738&utm_content=341851738&utm_source=hs_email
The US Food and Drug Administration (FDA) finalized guidance to industry on allowable communications to health care providers about off-label drug and device...
fdaguidancelabelcommunicationsraps
https://www.fda.gov/food/hfp-constituent-updates/fda-issues-final-guidance-industry-action-level-inorganic-arsenic-apple-juice
FDA announces availability of a final guidance for industry entitled "Action Level for Inorganic Arsenic in Apple Juice."
fdaissuesfinalguidanceindustry
https://www.fda.gov/food/hfp-constituent-updates/fda-issues-menu-labeling-guidance-utilizing-qa-format-and-graphics-address-concerns-offer-solutions
An update from FDA's Center for Food Safety and Applied Nutrition
menu labelingfdaissuesguidanceq
https://www.techtarget.com/healthtechanalytics/news/366616658/FDA-finalizes-AI-enabled-medical-device-guidance
Learn how new FDA guidelines could simplify the approval process for AI- and machine learning-enabled medical devices.
medical devicefdaaienabledguidance
https://www.foodsafetynews.com/2015/06/fda-publishes-draft-guidance-for-expedited-importer-program/
One requirement of the Food Safety Modernization Act (FSMA) is for the Food and Drug Administration (FDA) to develop a program to expedite food imports to
draft guidanceprogram foodfdapublishesexpedited
https://www.raps.org/news-and-articles/news-articles/2023/2/fda-draft-guidance-addresses-clinical-development
The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs to treat...
draft guidanceclinical developmentfdaaddressesdrugs
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/dental-bone-grafting-material-devices-class-ii-special-controls-guidance-industry-and-fda-staff
Developed as a special controls guidance to support the classification and reclassification of certain dental bone grafting material devices into class II.
bone graftingclass iidentalmaterialdevices
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/dental-noble-metal-alloys-class-ii-special-controls-guidance-document-industry-and-fda-staff
Exempts gold-based alloys and precious metal alloys for clinical use from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act.
noble metalclass iiguidance documentdentalalloys
https://www.biospace.com/fda-issues-first-draft-guidance-on-clinical-trials-with-psychedelic-drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of...
first draftclinical trialsfdaissuesguidance
https://www.raps.org/news-and-articles/news-articles/2022/12/this-week-at-fda-fda-approves-first-fmt-produc-(1)
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug and medical device regulation, and what we@re...
weekfdafirstfmtproduct