Impact Pharmaceutical Services

AUGUST 9, 2022

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. The Journey Leading to an Approved NDA. 5 clinical study reports.

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pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Hospital Pharmacy Europe

JUNE 8, 2023

A lack of transparency The importance of setting the primary outcome prior to commencing a study and not deviating from the original protocol, was first highlighted in 1990 by Jay Siegel , a physician and research scientist working for the FDA in the US.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. 2010 (IEC 62264-1 Mod): Enterprise-Control System Integration − Part 1: Models and Terminology.

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Packaging Documentation Communication Data Entry 52

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The Checkup by Singlecare

JUNE 14, 2024

A 2010 study suggests that people with severe liver failure and cholestatic liver disease often have low levels of vitamin D. Food & Drug Administration (FDA) like prescription drugs. In patients with liver cancer, vitamin D deficiency is associated with poorer outcomes. Are liver supplements beneficial?

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The Checkup by Singlecare

JANUARY 2, 2025

Klonopin is a brand-name medication that is FDA approved for certain types of seizures and panic disorder. Food and Drug Administration (FDA) to treat panic disorder and certain seizure disorders, such as Lennox-Gastaut syndrome, akinetic, and myoclonic seizures. Klonopin contains the active drug clonazepam.

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The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey. Published February 2, 2010. The Environmental Working Group (EWG) also has consumer resources that can help individuals source cleaner options.

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Health and Personal Care Stores Compounding Immunization Labelling 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. Endocr Rev.

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Documentation Dosage FDA Communication 98

Pharmaceutical Technology

FEBRUARY 1, 2023

Cases of palivizumab-resistant RSV strains have been documented as early as 2010, roughly 12 years after the mAb entered the market. In 2010, a palivizumab-resistant RSV strain was isolated from a preterm infant at 25 weeks of gestation, who was treated with three doses of palivizumab over a period of approximately 140 days.

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Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 64

The Thyroid Pharmacist

JANUARY 20, 2023

In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. 2010 Jan;76(1):7-19; Lee HW, Kim YH, Kim YH, Lee GH, Lee MY. 2010 Mar;62(2):145-55; Costa CARA, Quaglio AEV, Di Stasi LC. 2009;541-562.

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