The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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FDA Documentation 105

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. It can therefore support development of safe and effective products and medicines, while ensuring regulatory compliance. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.

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The FDA Law Blog

JANUARY 8, 2024

In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

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FDA 69

Pharma Marketing Network

JULY 26, 2023

While maintaining a vigilant approach to marketing compliance is crucial, the FDA may be strategically choosing to address more immediate public health concerns, leading to fewer marketing violation letters being issued.

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pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? It identifies the most used social media and digital channels and sets out specific guidance for each.

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BioPharm

MAY 10, 2023

Further, the guidance is to provide information on compliance with applicable regulatory requirements and recommendations.

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European Pharmaceutical Review

DECEMBER 19, 2023

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

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Packaging Documentation 94

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. It issued a draft guidance in 2017 which was subsequently revised in 2019. It issued a draft guidance in 2017 which was subsequently revised in 2019.

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OctariusRx

FEBRUARY 20, 2023

This is our first annual competency assessment focused on controlled substances and regulatory compliance. Ongoing education and assessments of staff in the handling of controlled substances not only helps with compliance, it’s also a great way to enhance patient safety. How are you assessing your staff?

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OctariusRx

JULY 20, 2023

If you need guidance on this topic or would like us to help you enhance patient safety and regulatory compliance, contact us for a free initial consultation. In this week’s newsletter to our clients, we address these questions and more.

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OctariusRx

NOVEMBER 20, 2023

Ongoing education and assessments of staff in the handling of hazardous medications is not only a regulatory requirement, but also a standard of good practice. With our annual assessment, you have both an education and an assessment tool to help you meet the regulatory requirement. How are you assessing your staff?

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European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

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Documentation 95

European Pharmaceutical Review

JULY 10, 2023

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes.

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The FDA Law Blog

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms.

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DiversifyRx

OCTOBER 27, 2023

Compliance for hazardous drugs will look wildly different based on the services, equipment, and types of medication you handle. Importance of Compliance Compliance with regulations pertaining to hazardous drugs is not merely a matter of legal obligation; it is an ethical and safety imperative.

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OctariusRx

AUGUST 28, 2023

Use our tool to help enhance patient safety and satisfy the regulatory requirement. In addition to our routine visits and guidance, at OctariusRx we offer several annual assessments including one on medication safety. And we accomplish regulatory compliance at the same time. How are you assessing your staff?

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OctariusRx

DECEMBER 27, 2022

Does your consultant pharmacist provide guidance on infection control? When was the last time you had a full assessment done to determine your level of compliance? There are many reasons why you need the guidance of a pharmacy consultant as part of your organization. How much does compliance cost?

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European Pharmaceutical Review

APRIL 2, 2024

Pharmacopoeia guidance on recombinant BET methods Currently, the regulatory landscape surrounding the use of (rFC) and (rCR) can be complex and confusing. It is important to understand the guidance provided by different pharmacopoeias. Additionally, there are positive regulatory developments on the horizon.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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OctariusRx

DECEMBER 12, 2022

How much compliance costs is tricky to calculate, but there are multiple examples of organizations who have paid millions of dollars in fines from regulatory agencies, and/or medical malpractice lawsuits. Lack of compliance can impact many different aspects of your facility. The post How much does compliance cost?

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pharmaphorum

JULY 1, 2022

Navigating The MDR and IVDR and Best Strategies for Compliance. In addition, the conference will consider the evolving regulatory landscape for digital health software. Gain insights from pharma regulatory experts in compliance and companion diagnostics. SAE Media Group’s Inaugural Conference…. 14 – 15 November 2022.

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OctariusRx

MARCH 11, 2024

Good medication management also makes regulatory compliance easier. If your systems are not quite up to regulatory standards, let us help you. If you do feel confident in your systems but worry about keeping up with the latest regulatory updates and survey trends, contact us so we can help make it easier for you.

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The FDA Law Blog

APRIL 8, 2024

Those numbers are the stars in the manufacturing universe that CDER uses to plot its regulatory course, so it’s of interest to see how they have remained consistent even if OPQ didn’t take the next step of connecting the points in those constellations. The role of technology on quality was another feature.

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IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. The regulatory body the Center for Medicare and Medicaid Services (CMS) is one of these departments. Gauthier, Pharm.D.,

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Impact Pharmaceutical Services

SEPTEMBER 18, 2023

As a small company, Yumanity did not have the experienced professionals needed to manage each stage of the manufacturing, quality, and regulatory processes (collectively called CMC – Chemistry, Manufacturing and Controls). Syner-G was flexible and provided the guidance and expertise Yumanity needed to ramp up and ramp down as needed.

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FDA 45

OctariusRx

OCTOBER 23, 2023

Do you work with experts in infection control and medication management to ensure you’re following the latest guidance? How is your facility ensuring compliance with all these issues? Who is keeping up with all the changes in clinical and regulatory guidelines and best practices? Do you review these routinely?

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OctariusRx

MARCH 3, 2024

Contact us for a free consultation today: we can help you set up a system to ensure compliance with licensing and accrediting agencies such as the Centers for Medicare and Medicaid Services (CMS) , Accreditation Association for Ambulatory Health Care (AAAHC) , Quad A and The Joint Commission (TJC).

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OctariusRx

NOVEMBER 28, 2022

Ongoing education and assessments of staff in the handling of hazardous medications is not only a regulatory requirement, but also a standard of good practice. With our comprehensive assessment, you can easily assess your staff and satisfy the regulatory requirement. And we accomplish regulatory compliance at the same time.

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Compounding 76

Impact Pharmaceutical Services

SEPTEMBER 15, 2023

Adhering to CLD best practices is time-consuming, labor-intensive, and costly, but streamlining strategies for accelerating timelines include screening technologies and purpose-fit cell lines to balance speed, quality, and compliance while optimizing cell culture conditions.

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Documentation Process Improvement Compounding 59

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’. More information about this process may be found in FDA’s 513(g) Guidance Document.

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FDA Documentation 100

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. Key changes to GAMP 5. The GAMP 5 Second Edition includes: Six completely new appendices.

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ISPE

MARCH 23, 2023

This blog post also seeks to provide discussion and guidance on some other topics related to “true copy” practices as below: The correct application of second person verification in the true copy process How to compliantly destroy original copies after verification of true copy.

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ISPE

JUNE 27, 2023

The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA). Pound mentioned the MHRA Innovation Office , again stressing the need for early engagement.

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ISPE

MARCH 16, 2023

Both approaches have significant implications for Annex 1 compliance and the role of Contract Manufacturing Organizations (CMOs) in production facilitating these trends. The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination.

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OctariusRx

AUGUST 22, 2022

Use our tool to help enhance patient safety and satisfy the regulatory requirement. In addition to our routine visits and guidance, at OctariusRx we offer several annual assessments including one on medication safety. And we accomplish regulatory compliance at the same time. How are you assessing your staff?

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ISPE

MAY 2, 2023

We know that for both new therapies and traditional therapies, there is opportunity to leverage innovative manufacturing processes, collective guidance, and an agile mindset to adapt to the current needs of patients. To ensure we are adapting with the needs of our world to drive reliable delivery of effective medicines.

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pharmaphorum

DECEMBER 13, 2022

Over the past few years, many clinical study administrators wanted to use the bring your own device (BYOD) model within their eCOA, but they were typically constrained by regulatory requirements or misunderstandings around the approach. Potential regulatory compliance: Regulators recently began recognizing the power of utilizing BYOD devices.

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