https://www.greenlight.guru/blog/intended-use-and-indications-of-use
One big difference is between bringing a novel product to market versus a "me-too" product. A me-too product is one in which you simply copy the 510(k) of your predicate device because that's the easiest path to market. Novelty involves a new indication for use, something that isn't on that predicate device's 510(k) submission.

https://www.fda.gov/files/drugs/published/Indications-and-Usage-Section-of-Labeling-for-Human-Prescription-Drug-and-Biological-Products-%E2%80%94-Content-and-Format-Guidance-for-Industry.pdf
81 indication to be listed in the INDICATIONS AND USAGE section of labeling. For drug 82 products other than biological products, absent an applicable waiver, "all indications listed in the

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/wording-therapeutic-indication-guide-assessors-centralised-applications_en.pdf
The therapeutic indication is the primary information on the use of a medicine. It should clearly state the disease/condition and population that a medicine is intended to treat. The consistency of wording within and across therapeutic areas. To improve clarity in the understanding of the wording of the indications for stakeholders.

https://www.medicinenet.com/indications_for_drugs__approved_vs_non-approved/views.htm
Indications for Drugs (uses), Approved vs. Non-approved. In medical terminology, an "indication" for a drug refers to the use of that drug for treating a particular disease. For example, diabetes is an indication for insulin. Another way of stating this relationship is that insulin is indicated for the treatment of diabetes.

https://en.wikipedia.org/wiki/Indication_(medicine)
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. [1] There can be multiple indications to use a procedure or medication. [2] An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular medical condition is present while an indication is a

https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses

https://dev.drugbank.com/guides/indications/overview
OTC (Over The Counter): OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf
The maintenance dose of WEGOVY is 2.4 mg injected subcutaneously once-weekly. If patients do not tolerate the maintenance 2.4 mg once-weekly dose, the dose can be temporarily decreased to 1.7 mg once-weekly, for a maximum of 4 weeks. After 4 weeks, increase WEGOVY to the maintenance 2.4 mg once-weekly.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/indications-and-usage-section-labeling-human-prescription-drug-and-biological-products-content-and
This guidance is intended to assist applicants in drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf
In a 30-week, open-label trial (NCT02128932), 1089 patients with type 2 diabetes mellitus were randomized to OZEMPIC 0.5 mg once weekly, OZEMPIC 1 mg once weekly, or insulin glargine once daily on a background of metformin (48%) or metformin and sulfonylurea (51%). Patients had a mean age of 57 years and 53% were men.

https://www.aafp.org/pubs/afp/issues/2020/0701/p30.html
The transfusion threshold of plasma for most adults should be an international normalized ratio > 1.5 to 1.6 in patients with active bleeding or at high risk of bleeding. 4 - 8. , 11. C

https://www.wolterskluwer.com/en/expert-insights/whats-the-value-of-the-drug-indication
With this data, the researchers identified a relationship between off-label drug use, drug class, poly-pharmacy, and adverse events. The key takeaway is the importance of capturing data — the indication and the reason for a prescription's discontinuation. While U.S. systems and standards currently support the capture and exchange of

https://www.ema.europa.eu/en/glossary/indication
Indication; Indication. A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease. Product emergency hotline. OUTSIDE WORKING HOURS. About us. What we do. Careers. Committees & working parties. Regulatory network. European experts. Languages.

https://www.euipo.europa.eu/en/designs/before-applying/product-indication
Product indication. As well as the images of your design, your application must also indicate the product that you intend to apply your design to (e.g. shoes, tables, toys, or any other type of product). When you file your application, you can easily choose a product indication using DesignClass. DesignClass contains a comprehensive list of

https://www.pm360online.com/best-practices-in-launching-new-products-and-indications/
by PM360 Staff October 23, 2013. Pharmaceutical and medical device companies looking to launch a new product—or even to introduce a new indication for an existing product—face more challenges than ever before. This new era is defined by shrinking pipelines, tightening budgets, the increasing influence of payers, the rise of ePatients, a

https://www.drugs.com/new-indications.html
New Indication Approved: March 18, 2024. Date of Original Approval: September 1, 2022. Spevigo (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis. FDA Approves Expanded Generalized Pustular Psoriasis Indications for Spevigo. Spevigo approval history.

https://docs.oracle.com/cd/F40923_01/books/OnDemOLH/ProductIndicationmain.html
Product Indications. Use the Product Indication pages to create, update, and track product indications. A product indication is a combination of a symptom or malady and the specific product or drug that alleviates the symptom or malady. Typically, a pharmaceutical sales representative details the product indication during a call with a health practitioner.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf
Indications and Usage (1) 8/2021 . and renal function in patients with impaired renal function, elderly Dosage and Administration (2.1) 6/2021 . patients, or patients on loop diuretics. Monitor for signs and symptoms Dosage and Administration (2.2) 8/2021 . during therapy . (5.2, 6.1) Dosage and Administration (2.3) - Removed 8/2021

https://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling
It includes indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, information about use in specific populations, and other

https://www.lawinsider.com/dictionary/product-indication
Product Indication means the clinical utility, intended use or clinical information of a particular Molecular Diagnostic Product, including, for example, the Product Indications identified in Appendices 1.5 and 1.10. Sample 1. Based on 2 documents. Remove Advertising. Product Indication means, on a country-by-country basis, any indication for

https://www.transfusionguidelines.org/document-library/documents/irradiated-blood-components/download-file/Irradiated%20blood%20components.pdf
Red cells become leaky after irradiation - potassium and free haemoglobin levels in the fluid increases. Therefore irradiated red cells can't be stored for as long as usual. Must be less than 14 days old and then only stored for a maximum of 14 days, compared to usual red cell storage life of 35 days. And it's not cheap!

https://www.sciencedirect.com/science/article/pii/S0939641122001291
For practicality reasons, the framework development was limited to oral dosage forms, but should be adaptable and applicable to other dosage forms as well ... Product differentiation to other products used in this indication: Acceptability, Identification: Safety, Medication errors: Product design (colors, imprints, shapes) Packaging requirements:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s070lbl.pdf
Recommended Dosage for NSCLC 2.4. Recommended Dosage for SCLC 2.5. Recommended Dosage for RCC 2.6. Recommended Dosage for cHL 2.7. Recommended Dosage for SCCHN 2.8. Recommended Dosage for Urothelial Carcinoma 2.9. Recommended Dosage for MSI-H/dMMR CRC 2.10. Recommended Dosage for HCC 2.11. Dose Modifications 2.12. Preparation and Administration

https://www.who.int/news/item/19-06-2024-medical-product-alert-n-2-2024--falsified-ozempic-(semaglutide)
Alert SummaryThis WHO Medical Product Alert refers to three falsified batches of OZEMPIC (semaglutide). This falsified product has been detected in Brazil (October 2023), the United Kingdom of Great Britain and Northern Ireland (October 2023), and the United States of America (December 2023), and was supplied in the regulated supply chain.OZEMPIC (semaglutide) is from a group of medicines

https://www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars
An interchangeable biosimilar product is a biosimilar that, depending on state pharmacy laws, may be substituted for the reference product at the pharmacy without the intervention of the

https://www.reuters.com/world/putin-congratulates-south-africas-ramaphosa-re-election-an-indication-warm-ties-2024-06-18/
Kremlin leader Vladimir Putin congratulated South Africa's Cyril Ramaphosa on his re-election as president on Monday, reflecting continued good relations with Pretoria despite uncertainty over

https://www.bloomberg.com/news/articles/2024-06-19/sheinbaum-sees-mexico-deficit-potentially-wider-than-forecast
Mexico's deficit in 2025 could reach as much as 3.5% of gross domestic product, the nation's president-elect said, an indication that she won't necessarily hold herself to an earlier