The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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FDA Documentation Labelling Communication 105

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. To achieve this, the U.S.

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Independent Pharmacies Packaging Documentation FDA 52

IDStewardship

APRIL 13, 2023

An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

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Hospitals Documentation Communication Patient Care 236

The Checkup by Singlecare

MAY 1, 2024

In 2024, the household income limit to qualify is under $27,180 for an individual or under $36,620 for a two-person household. In 2024, this is $30,120 for an individual and $40,880 for a couple. Necessary documentation and information Financial assistance programs may require proof of income. The application fee is $300.

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Health and Personal Care Stores Insurance Insurance Coverage Communication 52

Hospital Pharmacy Europe

JANUARY 11, 2024

A systems approach recognises the roles that all specialties play in patient care and encourages open communication that avoids practices that unnecessarily separate different aspects of the fluid management team into independent parts. Last accessed January 2024] Leach R et al. Clin Med (Lond) 2020;20(3):e26–31 Nasa P et al.

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Hospitals Patient Care Documentation Communication 105

Hospital Pharmacy Europe

MAY 9, 2024

With hundreds of invited speakers, the ESCMID Global 2024 gathering in Barcelona, Spain (27-30 April), welcomed approximately 16,000 delegates for five days of knowledge exchange, collaboration and innovation. In microbiologically documented HAIs, 32% of microorganisms were resistant to antimicrobials.

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Hospitals Communication Documentation Clinic Management 52

ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. 22 June 2023. EMA/321483/2020. 3 July 2020.

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FDA Dosage Documentation Communication 52

Pharmaceutical Technology

JUNE 20, 2023

GlobalData forecasts that the market for AI platforms for the entire healthcare industry will reach $4.3bn by 2024, up from $1.5bn in 2019 [i]. Consent documents often describe technical medical conditions and regulatory bodies are increasing pressure on sponsors to ensure that patient-facing information can be easily understood by patients.

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Medical Records Documentation Communication Dosage 52

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”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics. Please check your email to download the Report.

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Documentation FDA Hospitals Dosage 97