article thumbnail

Difference between Prescription vs Non-prescription drugs

FADIC

FDA approval process The FDA regulates both OTC and prescription drugs, but in different ways. Prescription drugs have to go through the New Drug Application (NDA) process. The application includes submitting clinical drug trial data and information about the manufacturing process.

article thumbnail

External control arms and debunking real-world data myths

pharmaphorum

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. This can require new processes, technologies and an organisation mind shift.”. In both situations, ECAs provide the foundation of comparison between an active treatment population and a control cohort.

Insiders

Sign Up for our Newsletter

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

Trending Sources

article thumbnail

Biogen admits slow Aduhelm launch, as scientists question label again

pharmaphorum

.” He blamed the poor performance on ” confusion, misinformation and controversy surrounding our data and the approval process.” “Our findings are concerning given the broad FDA labelling for aducanumab,” said corresponding author Timothy Anderson.

article thumbnail

How Pharmacists Can Use Artificial Intelligence To Advance Their Practice: Insights From ChatGPT

ID Stewardship

We’ll dive into the many ways AI can assist pharmacists, from streamlining medication dispensing processes to enhancing patient education. Personalized Medication Recommendations : AI algorithms can process patient data, such as age, gender, medical conditions, and allergies, to generate tailored medication recommendations.

article thumbnail

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means – The Drug Price Negotiation Program and Pending Legal Challenges

Big Molecule Watch

Congress left Medicare drug pricing to the drug manufacturers, pharmacies, and insurance plan sponsors to determine, and expressly prohibited the government from “interfering” in those private price negotiations under the so-called “Non-Interference Clause” of the Medicare Modernization Act of 2003.

article thumbnail

Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. Luckily, even without insurance coverage, this medication is available in generic form and is very affordable, usually costing between $15 to $40 per month. It’s a process and a journey, but it’s definitely worth it.

article thumbnail

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In the US, most private health insurers have been slow to cover the cost of anti-obesity therapeutics.