- Patient Medication Information 🔍
- Newly Added Guidance Documents🔍
- FDA Releases New Rule and Guidance for Prescription Drug ...🔍
- The FDA Announces New Prescription Drug Information Format🔍
- Office of Prescription Drug Promotion 🔍
- Medication Guides🔍
- Software Associated with Prescription Drugs🔍
- FDA Proposes New🔍
FDA Releases New Rule and Guidance for Prescription Drug ...
Patient Medication Information (PMI) - FDA
FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—"Patient Medication ...
Newly Added Guidance Documents | FDA
Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
FDA Releases New Rule and Guidance for Prescription Drug ...
The FDA's current rule requires television and radio commercials that promote the name of a drug and conditions of use to include a “major ...
Patient Medication Information (PMI) Proposed Rule | FDA
Yes. The proposed rule introduces Patient Medication Information or PMI. This would be a new type of Medication Guide that would require FDA ...
The FDA Announces New Prescription Drug Information Format
Under the new regulations, drug manufacturers are required to submit prescribing and product information in a structured product labeling (SPL) format that ...
Office of Prescription Drug Promotion (OPDP) News - FDA
On July 8, 2024, the U.S. Food and Drug Administration issued a revised draft guidance for industry entitled “Addressing Misinformation About Medical Devices ...
Medication Guides: Patient Medication Information - Federal Register
... Medication Guides (FDA-approved written prescription drug ... In this proposed rule, FDA is addressing legal issues relating to FDA's ...
Software Associated with Prescription Drugs - FDA
FDA has released a draft guidance, “Regulatory Considerations for Prescription Drug-Use-Related Software,” to share the agency's current ...
FDA Proposes New, Easy-to-Read Medication Guide for Patients ...
Today's proposed rule is a practical step towards improving the nation's health. Our public health mission is to ensure drugs and certain ...
Drug Interaction Information in Human Prescription Drug and ... - FDA
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft ...
Regulatory Considerations for Prescription Drug Use-Related ... - FDA
This guidance expands on and was developed in response to comments submitted in response to the Federal Register notice “Prescription Drug-Use- ...
3 The term drugs in this guidance refers to prescription human drug and biological products. ... For the most recent version of a guidance, check the FDA guidance ...
FDA issues final rule, guidance on importing prescription drugs
The Food and Drug Administration released a final rule allowing states, territories and Indian tribes to establish programs to import ...
FDA Updates Guidance to Further Empower Companies to Address ...
To help ensure the public has access to accurate, up-to-date, science-based information about FDA-regulated medical products, the FDA has ...
FDA Issues Final Rule and Guidance on Direct-To-Consumer ...
FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements · Related Posts · Latest Posts · PUBLISH YOUR CONTENT ON ...
Prescription Drug User Fee Amendments - FDA
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022, which includes the reauthorization of the ...
US FDA Releases Draft Guidance on Content and Format of ... - Freyr
In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity ...
FDA Releases Draft Guidance on LabelingFor Rx Drugs With ...
The Food and Drug Administration March 24 released a draft guidance for industry on the labeling for prescription drugs approved under the ...
FDA Releases Guidance on Prescription Drug Importation
In May 2022, the United States Food and Drug Administration (FDA) issued a Final Guidance, Importation of Prescription Drugs Final Rule Questions and ...
Comment from V McKenna - Regulations.gov
The Food and Drug Administration prescription drug advertising regulation ... FDA guidelines set out by the draft guidance. The current ...