Express Pharma

APRIL 6, 2023

These experts can provide guidance on the specific licensing requirements for the startup’s products, help prepare and submit the necessary documentation, and ensure that the startup is following the correct procedures throughout the licensing process.

Labelling 98

Labelling Dosage Packaging Documentation 98

FDA Law Blog: Biosimilars

JULY 29, 2024

As for minor changes that have minimal effect of product quality, the draft guidance notes that applicants can document those in their annual report, as opposed to a discreet filing with the agency. In our experience such a change is rare, but perhaps FDA is of the mind here to clarify how this might happen.

Biosimilars 64

Biosimilars Dosage Documentation 64

Syner-G

SEPTEMBER 20, 2023

If commercial, accessibility of cGMP API for proof of concept (POC) studies is much more possible in bulk in the open market, and may already be packaged in a suitable dosage form or strength for human trials. Repurposed commercial drugs also provide the advantage of having many patient years of reported safety data.

Drug Development 59

Drug Development Documentation Dosage Packaging 59

Pharmacy Joe

JANUARY 10, 2021

This data, together with the dose-related risk of GI bleeding from ketorolac documented in the prescribing information , has caused me to abandon using the 30 and 60 mg doses of ketorolac in my practice. This is yet another study demonstrating that the analgesic ceiling dose of ketorolac is 10 mg.

Clinical Pharmacology 40

Clinical Pharmacology Inpatient Dosage Documentation 40

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] The trial used dosages of 1, 2 and 3 grams of black seed oil per day, and found that the 2 gram per day dose was the most effective.

Diabetes 116

Diabetes Dosage Compounding Immunity 116

Viseven

JULY 16, 2024

Typically, HCPs establish a most likely diagnosis and prescribe a medication, often a blockbuster drug, and choose dosage based on the patient’s body weight. If it does not help, they change the dosage or choose another drug if possible. Trust the numbers and hands-on expertise.

Health and Personal Care Stores 52

Health and Personal Care Stores HIPAA Pharmaceutical Companies Pharmaceutical Companies 52

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

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111