The FDA Law Blog

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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IDStewardship

SEPTEMBER 2, 2022

CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. We need to stop thinking of guidelines as flat, text documents resembling journal articles. This type of communication has not changed significantly in hundreds of years.

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The Checkup by Singlecare

OCTOBER 16, 2023

The SSA offers two types of Social Security disability benefits for those who meet the agency’s strict definition of “disabled.” Below, we detail the 14 categories of conditions that qualify for SSA disability in adults and what you may be expected to provide for documentation for each. Where do you go to start the process?

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ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. Appreciate the regulatory agency’s definition of “the public interest.” Know the key topics. Tell other interested parties about your comment.

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The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e.,

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European Pharmaceutical Review

SEPTEMBER 26, 2023

However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

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DiversifyRx

MARCH 16, 2023

Provide them with the Parking Lot document HERE to supercharge your action! There are definitely some plusses for more frequent staff meetings. You can get more from your team and help them feel fulfilled by increasing communication with them as a group and one-on-one.

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pharmaphorum

JANUARY 27, 2023

What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Impact Pharmaceutical Services

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

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European Pharmaceutical Review

JANUARY 27, 2025

A clear and comprehensive definition of technology transfer is outlined in ICH Q10: The goal of Technology Transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation.

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Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.

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PQA

JUNE 27, 2024

Critical data elements required to calculate the measure are not yet standardized across participating SP systems, highlighting how differences in data definitions can impact the generalizability of measure rates. Meeting patients where they are” can help to improve communications and ultimately reduce TAT.

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Specialty Pharmacies Communication Packaging Documentation 40

DiversifyRx

JULY 11, 2024

To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request. Identifiers All products received must contain a product identifier. For additional information on identifying full-time employees, see [link].

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Independent Pharmacies FDA Documentation CPhT 52

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. It supports the analysis of Industry 4.0 initiatives.

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The deprescribing.org Blog

FEBRUARY 17, 2021

Access to what is described as a “controlled” environment definitely sets the stage for success. On the other hand, the ‘cons’ side challenged the role for hospitalists to deprescribe, quoting a lack of time, low priority in the face of acute medical issues, and risks to continuity of care with the community providers.

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Hospital Pharmacy Europe

JULY 3, 2024

The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation. ED pharmacists must know who to escalate their concerns to, as poor communication between professionals and organisations hinders patient safeguarding. Greenwood D et al.

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Hospitals Communication Patient Care Packaging 52

The FDA Law Blog

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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The Checkup by Singlecare

OCTOBER 30, 2023

While more research is needed to know if these products have a definite effect on escitalopram, it is possible that they can interfere with the way your body breaks down the medicine. Carefully read these documents as they contain important safety information, including information about interactions.

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ISPE

OCTOBER 26, 2022

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Each risk profile category contains a definition with examples. You may unsubscribe from these ISPE communications at any time. Leave this field blank.

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The FDA Law Blog

FEBRUARY 27, 2023

The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others. Helpful practitioner prescribing guidance is set forth in a simplified document here. 829(e); and 2) the modified registration requirement for online pharmacies. 21 U.S.C. § 21 U.S.C. § 802(54)(D)(i). Stay tuned.

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Controlled Substances FDA Documentation Communication 59

ISPE

JANUARY 9, 2023

It was time for ISPE to update this key guidance document to reflect technological progress. You may unsubscribe from these ISPE communications at any time. Since the publication of the first edition, GAMP ® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance.

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ISPE

JANUARY 8, 2023

Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context.

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ISPE

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M.,

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 15, 2023

21 , 22 In this context, the term recycle has a few definitions. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. Leave this field blank

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ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology.

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Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology.

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Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. This is the definition of the inductive approach to theory development. overall story the analysis tells, and generating clear definitions. Audio-visual communication.

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Communication Documentation FDA 52

ISPE

JULY 5, 2023

Due to the expanding workload of the ETP, CDER has begun implementing ETP program enhancements to improve strategy and operation and to enhance communication with those adopting new technologies. Eventually all CM technologies will graduate from the ETP.

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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

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. The update procedures should include how the AI-DSF modifications will be implemented and communicated to end users. Impact Assessment The Impact Assessment documents the benefits and risks of implementing the AI-DSF and the mitigations for the identified risks.

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FDA Documentation Labelling Method Validation 71

The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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