FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

This letter, dated August 29, 2024, (at the height of the US Open, no less) comes not even a month after OPDP’s last letter from August 1, and a little over a month since another celebrity-related Untitled Letter, both of which we blogged about here. Advantage, OPDP.

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Labelling Adverse Reactions Dosage 59

Express Pharma

JUNE 2, 2023

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. Incidences of these fraudulent products have posed grave threats to individuals relying on medications for their well-being.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

pharmacy mentor

SEPTEMBER 2, 2024

In this blog, we will be looking at the short, medium and long term to understand what parts of pharmacy are most likely to be taken over by AI and where the human touch will still be needed going forward. Dosage Recommendations : AI tools such as Dosis can analyse patient-specific data (e.g.

Customer Service 52

Customer Service Medication Therapy Management (MTM) Dosage Scheduling Appointments 52

Express Pharma

APRIL 13, 2023

In a world where ‘natural’ and ‘organic’ have become synonymous with sustainability, labelling a product ‘synthetic’ seems antithetical. They are less toxic and have a higher degree of solubility, thus making them better candidates for liposomal-based drug delivery systems, especially for parenteral administration and inhalation dosage forms.

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Vaccines Dosage Pharmaceutical Manufacturing Labelling 97

RX Note

JULY 13, 2023

Australian Medicines Handbook You will find me frequently citing the Australian Medicines Handbook throughout this blog. Only then can one have a broader and clearer overall picture. Undoubtedly, it remains my favourite drug reference (although I cannot afford the latest edition).

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Compounding Hospitals Dosage Labelling 40

The Happy PharmD

APRIL 26, 2023

I decided to calculate the dosage quickly. A 5ml dosage contains 1.8g Or maybe there might be a different dosage of what you (the resident) want. It was available at a dosage of 0.5mg/5 ml. Writing the dosage as a percentage. They would be underdosing themselves and taking the wrong dosage.

Dosage 52

Dosage Hospitals Pharmacy Technician Prescription Filling 52

Pharmacy Joe

MARCH 7, 2024

Back in episode 473 , I talked about the evidence behind the discrepancy between the labeled dose and the analgesic ceiling dose of IV ketorolac. There is similar data on the ceiling dose of ibuprofen as well. 225 patients were split evenly between groups.

Inpatient 52

Inpatient Dosage Labelling 52

Pharmacy Joe

NOVEMBER 10, 2021

The RECOVERY Trial, which is a randomized, controlled, open-label trial, underway at 177 hospitals recently published results of using colchicine in patients admitted to hospital with COVID-19. The colchicine dosage was also reduced by 50% for patients under 70 kg or with creatinine clearance under 30 mL/min.

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Hospitals Inpatient Dosage Labelling 40

Express Pharma

MAY 10, 2023

Not only can that issue compromise the formulation and patient health, but the disappearance of a labeled ingredient can land drug manufacturers on the wrong side of the law and potentially find professionals close to the product manufacture in jail. That can translate to a loss of solvent.

Packaging 97

Packaging Dosage Labelling Immunity 97

Pharmacy Joe

SEPTEMBER 20, 2021

Back in episode 473 , I talked about the evidence behind the discrepancy between the labeled dose and the analgesic ceiling dose of IV ketorolac. There is similar data on the ceiling dose of ibuprofen as well. 225 patients were split evenly between groups.

Inpatient 40

Inpatient Dosage Labelling 40

Viseven

APRIL 11, 2023

This may include blog posts, whitepapers, videos, podcasts, or infographics. The most suitable formats for pharma are eDetailers, infographics, case studies , blog posts, articles, and so on. For example, blog articles and social media posts may be most effective during awareness.

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Customer Service Pharmaceutical Companies Pharmaceutical Companies Dosage 40

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Thirty-eight states currently authorize marijuana in different dosage formulations for specific qualifying medical conditions. FDA analyzed the following indications: anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting (e.g.,

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

The Thyroid Pharmacist

JUNE 30, 2023

Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. Many times, people have been able to eliminate their symptoms and reduce their dosages of medications. These include Crohn’s, MS, and Hashimoto’s, as well as other immune system-related conditions such as cancer and HIV/AIDS.

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Compounding Immunity Immunization Compounding Pharmacies 98

FDA Law Blog: Biosimilars

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Dietary Changes.

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Dosage Labelling Communication Compounding 122

FDA Law Blog: Biosimilars

MAY 21, 2024

DEA further believes that factual evidence (including scientific data) and expert opinions with additional data on different forms, formulations, delivery methods, dosages, and concentrations “may be relevant.” The eight factors with a summary of relevant findings follow. Basis at 63-64.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products.

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95