pharmaphorum

SEPTEMBER 29, 2022

If so, developers must develop and execute on a regulatory strategy. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. Food and Drug Administration (FDA) regulation as a medical device. General Wellness Products.

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FDA Documentation 101

European Pharmaceutical Review

FEBRUARY 21, 2023

The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. What limitations in the regulatory framework did Celadon need to navigate?

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ISPE

AUGUST 30, 2022

Regulatory Landscape for Raw Materials: CMC Considerations. Regulatory Landscape for Raw Materials: CMC Considerations. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Regulatory Expectations. Trudy Patterson. Jacqueline E.

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ISPE

MAY 9, 2023

Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. Alternate approaches to meeting local requirements emerged during the COVID-19 pandemic: one example is the acceptance of electronically generated regulatory documents (e.g.,

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ISPE

SEPTEMBER 11, 2023

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques. ™ technologies.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

European Pharmaceutical Review

MARCH 14, 2023

This is due to the regulatory requirements imposed on parallel imported medicinal products in various Member States, the fulfilment of which often requires repackaging. Nevertheless, the parallel import of medicinal products involves, in many cases, interference with the exclusive rights of trademark proprietors.

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Packaging Generic Medicine Labelling Pharmaceutical Companies 85

ISPE

JULY 6, 2023

Although much focus by industry and regulatory authorities remains on manufacturing quality, and rightly so, a host of other major risks must be managed, including financial, investment, operational, environmental, regulatory, supply chain, legal, and strategic risks.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Viseven

MAY 15, 2023

Depending on the marketing approach, some pharma marketing specialists divide e-detailing into two categories: self-detailing and remote detailing. Powered by modular content, eWizard allows your company to reuse pre-approved content blocks and tremendously simplify medical, legal, and regulatory affairs for e-detailing.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52

PharmaShots

MARCH 9, 2023

In 2016, she received a special career-recognition award from Fundamed Foundation (a non-profit Spanish foundation) in the category of the most influential pharmaceutical executive from Spain over the past 15 years Education: Belén is an alumnus of the University of Alcala de Henares as an MS, Ph.D., Vita Award for Clinical Research.

FDA 40

FDA Pharmaceutical Companies Pharmaceutical Companies Immunization 40

ISPE

JULY 10, 2023

To this end, we need to understand what ChatGPT is: As an LLM within the space of generative AI, it can create content, and therefore contrasts other objectives of machine learning (ML) to generate point estimate predictions or suggestions on categories or classifications. Additionally, more specialized LLMs are likely to gain traction.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. This also includes biologics and biosimilars, which go through a different regulatory journey. Strong legal footing and manufacturing base vital.

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FDA Medical Schools Dosage 119

The FDA Law Blog

AUGUST 17, 2022

And FDA provided no dividing line between self-fitting and regular OTC, leaving the self-fitting hearing aid category vulnerable to evasion. Legally marketed devices that do not need a new 510(k) must comply with these regulations by April 14, 2023. (FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)

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ISPE

MARCH 8, 2023

1 UK Medicines and Healthcare Products Regulatory Agency. “A Pharmaceutical Compounding: A History, Regulatory Overview, and Systematic Review of Compounding Errors.” 49 Another major problem can arise from the presence of legally ambiguous gray areas. China Regulatory and Market Access Pharmaceutical Report 2014.”

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pharmaphorum

JANUARY 4, 2023

The Proposal cites a number of reasons and studies that contributed to the desire for regulatory reform in the health data sector. Further, there are question marks around how the secondary use concept will sit alongside the GDPR, under which a legal basis is required for data users to process health data for secondary uses.

Medical Records 97

Medical Records Insurance Hospitals 97

Viseven

SEPTEMBER 14, 2023

Procurement methods, at any health system level, typically comprise the following categories: restricted tender, open tender, direct procurement, competitive negotiation, and international and local shopping. What are the Main Pharmaceutical Procurement Methods? The range of functionalities within e-procurement platforms notably varies.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

The FDA Law Blog

OCTOBER 6, 2023

The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.

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FDA Labelling 64

ISPE

OCTOBER 27, 2022

It is a regulatory requirement that different VV types are manufactured in segregated manufacturing suites. As the majority of C> modalities fall within the BSL-2 category, BSL-2+ provides a robust strategy to ensure the facility will be suitable for a wide range of modalities.

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Packaging Communication Immunization Vaccines 52

pharmaphorum

JANUARY 12, 2021

Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation. A key commitment in the deal is to reach the upper quartile of uptake in relation to comparator countries for the five highest health gain categories of treatments.

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Documentation 68

Pharma Marketing Network

NOVEMBER 4, 2020

RJ (PMN): One of the things I’m thinking about as you’re describing the kind of multiple permutations that could evolve and I’ve seen this in some of the examples you say to be for about like AI creating its own musical composers which have gotten really quite good and and fascinating. So Theraflu, Advil, Biotene and ChapStick.

Compounding 52

Compounding 52

Viseven

JULY 12, 2022

Divide your content into a few categories to make it varied and engaging. These categories can include short articles about news and updates in your company (its services and products), research-based long reads, infographics about industry trends, and beyond. Write on multiple topics.

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Communication Documentation Hospitals 52

Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. This de facto decriminalization of personal drug importation means that the U.S.

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FDA 84