Remove Containment Remove In-Vitro Remove Sales
article thumbnail

Best Toenail Fungus Treatment Products

Druggist

Amorolfine 5% nail lacquer (brand name: Curanail 5% w/v Medicated Nail Lacquer) is available as general-sale medication, which can be purchased in most supermarkets and pharmacies. The main products used for toenail fungus treatment are available in most pharmacies, supermarkets and perhaps with the best range of products found online.

article thumbnail

Best OINTMENT or CREAM for insect bites

Druggist

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). For many customers, ointment or cream for insect bites is the first line of rescue in stings management. What causes bite itchiness and redness? Hydrocortisone cream for insect bites.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation

Camargo

Per the FDA’s guidance on RPDD : In vitro data supporting the mechanism of action of the drug in the disease or in a related disease may suffice for rare pediatric disease designation, whereas that level of data would not generally suffice for orphan-drug designation. Criteria for Rare Pediatric Disease Designation.

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

article thumbnail

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Orphan Drug Act defines a rare disease or condition as one (a) which affects less than 200,000 persons in the US or (b) for which there is no reasonable expectation that the cost of developing a drug and making it available in the US will be recovered from sales in the US. Criteria for Orphan Drug Designation. Scientific Rationale.

article thumbnail

Avacta Announces Collaboration Agreement With Bruker

The Pharma Data

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

Reagent 52
article thumbnail

XPhyto Announces RT-PCR Test for Point-of-Care COVID-19 Detection

The Pharma Data

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp.

RNA 52