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.

FDA 105

FDA Documentation Labelling Communication 105

The FDA Law Blog

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

FDA 75

FDA Documentation Packaging Communication 75

IDStewardship

SEPTEMBER 2, 2022

Article Posted 2 September 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. Interview with: Michael Long, Ph.D. BCPS, BCIDP.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

ISPE

DECEMBER 6, 2022

Tue, 12/06/2022 - 11:48. 6 December 2022. Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion. The same holds for whether we are paper based or digital; we should understand that documentation, in any form, should be kept professional and on-topic.

Documentation 52

Documentation Communication 52

European Pharmaceutical Review

JUNE 27, 2022

A guidance document has been released to support these activities. The Kigali Summit on Malaria and NTDs , hosted by His Excellency (HE) Paul Kagame, President of the Republic of Rwanda, on Thursday 23 June 2022, gathered world leaders to commit to ending these devastating diseases by the end of 2030. — GSK (@GSK) June 23, 2022.

Vaccines 90

Vaccines Communication Documentation Compounding 90

The Checkup by Singlecare

OCTOBER 16, 2023

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. The SSA also requires persuasive medical documentation from a healthcare provider. (This is not to be confused with Medicare Part A and Part B.)

Documentation 105

Documentation Immunization Mayo Clinic Insurance 105

ISPE

SEPTEMBER 28, 2023

billion in 2022. California institutions were the top recipients of NIH funding in 2022; spending in R&D and innovation through partnerships and alliances has grown over the past two years. California accounted for 15–18% of patents granted in core life sciences applications between 2018 and 2022. billion in 2019 to $17.3

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

OCTOBER 31, 2022

As of September 2022, FDA has now announced the conclusion of the pilot program. FDA proposes that “modern mechanisms that support clear and consistent communication of device information could facilitate efficient device review activities” and notes that they “consistently observed the need for structured data.”

FDA 72

FDA Documentation Communication 72

Impact Pharmaceutical Services

MAY 4, 2022

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager. 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.

FDA 52

FDA Documentation Communication 52

ISPE

OCTOBER 28, 2022

Fri, 10/28/2022 - 11:30. November / December 2022. 1 November 2022. The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. Audio-visual communication. Text communication. Technology and communications requirements.

Communication 52

Communication Documentation FDA 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Documentation 52

Documentation Communication FDA 52

Hospital Pharmacy Europe

JUNE 8, 2023

They examined possible changes using three different methods: the history of tracked changes on ClinicalTrials.gov ; self-reported changes noted in the article; and changes reported within the protocol, including all available protocol documents. Nevertheless, it is incumbent on trialists to communicate such changes.

Documentation 52

Documentation Communication Patient Care Hospitals 52

IDStewardship

APRIL 13, 2023

CMS regulations on antimicrobial stewardship for acute care ( QSO-22-20-Hospitals ) went into effect mid-2022. 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.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 Eurostat (2022) “How many citizens had basic digital skills in 2021?”

Packaging 81

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 81

Hospital Pharmacy Europe

JANUARY 19, 2023

Accompanying leaflets for patients have been developed and also digital versions of the documentation. Community pharmacy teams commonly identify training in suicide prevention as one of their key needs and Dr Gorton said that some 72,000 patient-facing community pharmacy staff had already completed the Zero Suicide Alliance training.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

PQA

FEBRUARY 23, 2023

In 2023, PQA’s COPD Treatment Ratio (CTR) TEP will conclude following its launch in 2022. Self-nominations for these TEPs will be communicated to PQA members in the second or third quarter of 2023, and we encourage interested PQA members to submit a self-nomination for consideration. PQA will launch two additional TEPs in 2023.

Specialty Pharmacies 40

Specialty Pharmacies Documentation Communication 40

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. Supreme Court takes up the case in 2022 and ruled in favor of the 340B hospitals. 2022: As referenced above, the U.S.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

ISPE

MARCH 20, 2023

The Challenge New approaches and technical possibilities are constantly being developed to enable systems to communicate with each other and exchange data. Checklist 1 offers detailed guidance by allocating and documenting the responsibilities in the affected processes and overall system context.

Documentation 97

Documentation Communication 97

pharmaphorum

SEPTEMBER 16, 2021

The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. April 2022 is the start, not the end of the systematisation journey. Technology can also join up and improve services.

Community Pharmacies 113

Community Pharmacies Patient Care Medical Records Documentation 113

The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. It’s worth considering how you can do so, such as through building trust and open communication. American Medical Association (2022) The State of Health Disparities in the United States. health care today.

Insurance Coverage 52

Insurance Coverage Communication Documentation Compounding 52

The Checkup by Singlecare

MARCH 16, 2023

a clinical pharmacist at Walgreens in McKinney, Texas, and a 2022 Best of the Best Pharmacy Awards winner. But due to changes in the healthcare industry and technological advances, their roles have become essential in the day-to-day operations of pharmacies, says Sue Ojageer , Pharm.D.,

Data Entry 52

Data Entry Long-Term Care Facilities Insurance Immunization 52

The FDA Law Blog

NOVEMBER 15, 2022

To submit a small business certification request: Collect tax documentation. Send documents to FDA. If you are a foreign business, we recommend that you allow for additional time to prepare your documents. When your documents are ready, send them to the following address: FY 20__ MDUFA Small Business Qualification.

FDA 59

FDA Documentation Communication 59

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Internet] Burak. cited 2023July]. Kartoglu U. Internet] WHO.

Vaccines 98

Vaccines Communication Immunization Documentation 98

ISPE

NOVEMBER 21, 2022

Mon, 11/21/2022 - 10:06. 21 November 2022. All of this must of course be verified as part of supplier evaluation, and the criticality of applications dependent on cloud resources must be clearly stated and agreed in a contractual document. IT Infrastructure in the Current Life Science Company Environment. Trudy Patterson.

Documentation 98

Documentation Communication 98

pharmaphorum

SEPTEMBER 14, 2022

As will be discussed at the 2022 DPharm annual conference in Boston, IQVIA, a global clinical research organization, surveyed more than 6,400 participants across the U.S. So, it is critical that sponsors better promote DCT models and communicate the ease of the trial experience at every touchpoint when recruiting. Long-term partners.

Vaccines 98

Vaccines Medical Records Documentation Communication 98

The FDA Law Blog

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

FDA 59

FDA Packaging Documentation Labelling 59

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. J Crit Care 2022 Oct;71:154122 Malbrain MLNG et al. Clin Med (Lond) 2020;20(3):e26–31 Nasa P et al.

Hospitals 105

Hospitals Patient Care Documentation Communication 105

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 16:20. November / December 2022. 1 November 2022. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search?

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 16:20. 1 November 2022. Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? 12 (2022): 1125–1126.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

Digital Pharmacist

NOVEMBER 21, 2022

On October 7 th , 2022 the U.S. b) Marketing and Communications Oversight. Medicare beneficiaries will be secured by CMS’s finalization of revisions to marketing and communications regulations that will guarantee they get accurate and understandable information about their coverage. Road Towards Approval.

Communication 98

Communication Documentation Immunization Vaccines 98

ISPE

SEPTEMBER 12, 2022

2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. Mon, 09/12/2022 - 15:18. September / October 2022. 2022 ISPE Aseptic Conference: Regulatory Panel Discusses ATMPs, Data Integrity, Inspections, & More. 12 September 2022. 2022 PIC/S Chair, Sr. Rick Friedman.

FDA 52

FDA Documentation Communication 52

The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

Documentation 52

Documentation Labelling Communication FDA 52

ISPE

NOVEMBER 28, 2022

Mon, 11/28/2022 - 08:17. 28 November 2022. The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

NOVEMBER 9, 2022

Another factor in this enhanced adaptability is development of in-house expertise that enables more efficient interaction by simplifying communication channels. Technology transfer of the process from development to manufacturing involves generating a wide variety of documentation, data and training. 2021 [Cited 16 September 2022].

Vaccines 94

Vaccines Documentation Communication Hospitals 94

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

FDA 105

FDA Documentation Communication 105

ISPE

JULY 19, 2023

™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. and management communication strategy. In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed.

Documentation 98

Documentation FDA Labelling Communication 98

PQA

SEPTEMBER 28, 2022

Published in January 2022, it is the first and only national resource that documents real-world SDOH services that are promising for improving the quality and safety of medication use with a focus on screenings, referrals and interventions conducted by or involving pharmacists or pharmacies.

Documentation 52

Documentation Communication 52