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Optimising project management in pharma: 8 steps toward efficiency

Express Pharma

It facilitates efficient planning, communication, and project execution between pharmaceutical companies and their CDMO. Thus, project leaders must enforce consistent and coherent communication channels to ensure alignment on project goals, timelines, and expectations as well as sharing of data using secure platforms.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Ecommerce Prescribing Clinic – The Ultimate Tech Stack

pharmacy mentor

This is great as it allows prescribers to provide extra information about treatments and facilitates communications even when someone needs information out of hours. Built-in Messaging System – Enables direct communication between patients and pharmacy or prescribers for queries or clarifications. That can help protect your reputation.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.

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NHC Comments on Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents (CMS-10882) – IRA

Putting Patients First Blog

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels. However, the involvement of the company should always be stated.

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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

FDA Law Blog: Biosimilars

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.