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”. Download the full report to understand what to expect and how to align your strategies for success. Fighting Entresto generics. By GlobalData.

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The FDA Law Blog

NOVEMBER 15, 2022

User fees are fees that FDA collects from “companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.” These fees supplement the annual funding Congress provides for FDA. These fees are negotiated by FDA and industry every five years.

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Impact Pharmaceutical Services

AUGUST 9, 2022

Download a PDF of this case study. Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. The Journey Leading to an Approved NDA. 5 clinical study reports. 5 clinical study reports.

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Pharmaceutical Technology

APRIL 26, 2023

The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Please check your email to download the Buyers Guide.

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Pharmaceutical Technology

JUNE 30, 2022

To find out more, download the whitepaper below. All of this - combined with Georgia’s attractive investigator rates and the low cost of clinical trial conduct - has created an environment ripe with opportunities for sponsors.

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Pharmaceutical Technology

SEPTEMBER 1, 2022

The range includes units compliant with FDA 510(k) for medical devices. To find out more about Pall filters and water management services, download the document below. They are available with 0.2-micron

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Pharmaceutical Technology

APRIL 13, 2023

Alongside the use of patient Electronic Health Records (eHRS), eConsent is now often used to request, confirm, and document informed consent for trials, and electronic trial master file (eTMF) systems utilise both hardware and software to manage clinical trial data. For further information, download the paper below. [1]

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. 13.00 – 17.00.

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ISPE

SEPTEMBER 11, 2023

www.fda.gov/media/162157/download 7 Okwudire, C. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. Discussion paper.

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Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). For more information on this, please download our white paper. For more information, please download our white paper.

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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. You can download their mobile app from the apps store on your mobile phone. The EPA has a website called AirNow site.

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Pharmaceutical Technology

MARCH 2, 2023

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive steps to ease the pharmaceutical’s industry transition to these advanced processes, states the announcement.

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The Thyroid Pharmacist

JUNE 14, 2023

A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! For more information on resolving your thyroid symptoms, download my free Thyroid Symptom Hacker eBook below! His wife had Hashimoto’s.)

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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.

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The FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. She indicated the requirements went out for comments and expects the group to finalize the document by early next year.

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