The FDA Law Blog

JUNE 27, 2023

FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH.

FDA 59

FDA Documentation Labelling Communication 59

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Establish an open line of communication with your residency program director Different strokes for different folks! Knowing how the RPD communicates is important.

Communication 130

Communication Documentation Vaccines 130

Hospital Pharmacy Europe

JANUARY 17, 2024

Doctors should inform male patients who are taking valproate about the possible risk and discuss the need to consider effective contraception, for both the patient and their female partner,’ the PRAC said. But this will not have ‘implications’ for the new strengthened safety rules coming in this month, according to the MHRA.

Communication 105

Communication Documentation Hospitals 105

Omnicell

JANUARY 10, 2023

Standardizing an interoperability solution that supports information exchange creates better medication management practices for nurses and improved patient engagement. The EHR-ADC interoperability automatically identifies variances between medications dispensed from the cabinet and those documented as being administered and drives action.

Omnicell 98

Omnicell Cerner Medication Dispensing Documentation 98

Board Vitals - Pharmacist

DECEMBER 1, 2023

Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” Regardless of the term you use, communicating with patients in order to improve their care, compliance, and satisfaction is a worthy goal. It’s much easier said than done.”

Communication 98

Communication Patient Care Documentation Insurance 98

pharmaphorum

MAY 25, 2022

“Where it is impossible to restrict access to HCPs, due to the congress platform or equivalent, there must be a clear statement to the attendee that the materials/communication are designed and intended for HCPs only.”. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country.

Documentation 105

Documentation Communication Labelling 105

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. BCPS, BCIDP.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

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.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. Furthermore, digitisation has simplified the process of gaining information on the drugs being prescribed.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Communication Documentation 52

pharmaphorum

NOVEMBER 15, 2021

These must be submitted into the Clinical Trials Information System (CTIS), part of the EU Database, portal, no later than 12 months after the protocol-defined end of the study. The lay summary project, then, fulfils a “current and future need” to provide information in a “transparent, reliable, objective way”. Boosting engagement.

Documentation 97

Documentation Communication Hospitals 97

Pharmacy Is Right For Me

APRIL 4, 2023

Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC). This empowers care providers with critical patient information. It also improves care coordination and eliminates communication gaps.

Hospitals 130

Hospitals Communication Medical Records Dosage 130

The FDA Law Blog

AUGUST 9, 2023

The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer. The transferring or receiving pharmacist must ensure that the populated information is complete and accurate. (to be codified at 21 C.F.R. cannot be altered during the transmission.

Controlled Substances 52

Controlled Substances Documentation Communication 52

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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FDA Documentation Packaging Communication 75

The Checkup by Singlecare

NOVEMBER 9, 2023

This person may go by other names in the document, depending on the state you live in. The benefits of a medical power of attorney Having a signed and notarized medical power of attorney offers many perks, and it is one of the most important documents you’ll create in a lifetime. A copy should also be shared with family members.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Communication Hospitals 52

ISPE

SEPTEMBER 14, 2022

introduces it thus: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. Wikipedia 2.

Documentation 97

Documentation Communication 97

The Checkup by Singlecare

APRIL 5, 2024

Here’s all the information you need to determine whether your Blue Cross Blue Shield (BCBS) plan could provide some assistance. Commonly, BCBS requires proof of a diagnosis of Type 2 diabetes and documentation that the patient has not adequately responded to other diabetes medications before approving Ozempic,” he says.

Insurance 78

Insurance Documentation Insurance Coverage FDA 78

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. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

Documentation 52

Documentation Communication 52

The Physician Pharmacist

MAY 16, 2023

He explains that clinical informatics focuses on one-on-one interactions with patients and how to improve the user interface to make the documentation process more seamless. One of the most significant benefits is improved interoperability , which allows healthcare professionals to share patient information more easily.

Documentation 52

Documentation Patient Care Mayo Clinic Communication 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision. Prospects of clinical dose companies in contract marketing.

Communication 40

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

The QA Consultant supported the product development program by review and approval of documents such as Quality Agreements, Master and Executed Batch Manufacturing records, batch related Change Controls, Deviations, Investigations, analytical data, Validation reports and Stability protocols.

Documentation 40

Documentation Communication 40

pharmaphorum

OCTOBER 27, 2022

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.

Communication 96

Communication Packaging Documentation Pharmaceutical Companies 96

IDStewardship

APRIL 13, 2023

PACCARB provides advice, information, and recommendations to the Health and Human Services Secretary (HHS) regarding programs and policies intended to support and evaluate the implementation of U.S. Today this Taskforce is known as The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, or PACCARB.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

The FDA Law Blog

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. In doing so, we hope FDA will adopt an open mind when it comes to expanding the topics on which it will consider providing informal feedback.

FDA 45

FDA Documentation Communication 45

ISPE

NOVEMBER 23, 2022

Continue active cooperation with strategic partners , encourage PIC/S membership and strengthen PIC/S communications and engagement. Build PIC/S operational capacity by securing new revenue streams, implementing fiscally sound financial plans and increase transparency to the PIC/S community.

Documentation 98

Documentation FDA Communication 98

ISPE

DECEMBER 6, 2022

The culture needs to instead shift to the risk/reward sectioning of information, where we look at the benefit of broad access to information against the threat of data theft, loss, or inappropriate use. Information in the wrong hands. Dead ended information not getting addressed. Perceived Risks. Actual Risks.

Documentation 52

Documentation Communication 52

DiversifyRx

OCTOBER 27, 2023

Pharmacists need to communicate with the prescribing physician, review the patient’s prescription history through the PMP (Prescription Monitoring Program), and document the conversation in the patient’s profile. Without proper documentation, it’s as if the conversation never happened.

Independent Pharmacies 52

Independent Pharmacies Controlled Substances Documentation Communication 52

ISPE

APRIL 19, 2023

An effective project manager understands the associated processes of the critical systems/equipment under test and is able to identify any issues/misalignments with expectations that may compromise the qualification performance of another system or equipment and communicate/correct them accordingly. For example: 1.

Documentation 52

Documentation Communication 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Communication and follow-up with the physician. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Adherence management. Benefits investigation. Dispensing of speciality pharmaceuticals and shipping coordination.

Documentation 45

Documentation Clinic Management Communication Patient Care 45

pharmaphorum

FEBRUARY 4, 2021

There needs to be widespread information available to the general public, training for professionals and patients and targeted communications to health and political institutions. Giuseppe Recchia, director of Tendenze Nuove and promoter of the project said several steps must be taken to integrate DTx into Italy’s healthcare system.

Documentation 139

Documentation Communication 139

pharmaphorum

JANUARY 6, 2021

According to a tender document , the “extreme urgency brought about by the COVID-19 pandemic situation” justified the decision not to open up the contract to competition. The document added that the technical demands for the project mean that X-Labs is the only provider capable of fulfilling the contract.

Documentation 64

Documentation Communication 64

The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Documentation 45

Documentation FDA Labelling Communication 45

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. percent as EU average with some Member States as high as 25 percent).

Packaging 84

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 84

pharmaphorum

NOVEMBER 20, 2020

Behind the Mask is a global research initiative to document health experiences during the COVID-19 pandemic and beyond. Havas Health & You (HH&Y) has launched the details of a long-term global research project, Behind the Mask, a longitudinal, multi-armed study that focuses on documenting the ongoing evolution of health and wellness.

Documentation 52

Documentation Communication Medication Delivery 52

pharmaphorum

AUGUST 19, 2021

The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. While the methods and approaches necessary to achieve these qualities will differ from trial to trial, their validity, said the document, is universal. Read the full document here.

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Documentation Communication 105

Pharmaceutical Technology

JUNE 15, 2023

AI can help teams collaborate and share knowledge to empower better-informed decisions. AI helps unlock meaningful questions in the exploration phase, improves predictive models using sophisticated data science techniques and can even inform product marketing. But that’s not all there is to modern knowledge management.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

The information contained within the download document is intended for manufacturers, suppliers, distributors, pharmaceutical executives, medical representatives, distributors, pharmacists, business development managers, retail salesmen, sales managers, product marketing managers, and any other individual involved in drug injectables marketing.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 52

pharmaphorum

APRIL 21, 2021

Seqster pulls in information from electronic health records, pharmacy, lab, and genomic data, as well as data from fitness wearables – irrespective of the healthcare system in which they were generated – placing it in a patient dashboard that the company says is secure and real-time.

Documentation 59

Documentation Communication 59