Titles
- E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff1
- Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring: guidance for industry and Food and Drug Administration staff1
- Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry1
- Evaluation of gastric pH-dependent drug interactions with acid-reducing agents: study design, data analysis, and clinical implications : guidance for industry1
- Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Foreign supplier verification programs for importers of food for humans and animals: guidance for industry1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- Format and content of a REMS document: guidance for industry1
- Fostering medical device improvement: FDA activities and engagement with the voluntary improvement program : guidance for industry and Food and Drug Administration staff1
- General clinical pharmacology considerations for neonatal studies for drugs and biological products1
- General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff1
- Homeopathic drug products: guidance for FDA staff and industry1
- Human gene therapy for neurodegenerative diseases: guidance for industry1
- Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry1