STAT

AUGUST 16, 2023

 The company — which is a major supplier of non-human primates to corporate, government, and academic research laboratories — received a voluntary request last May for documents dating back to December 2017 about importing non-human primates from Asia, according to a regulatory filing.

Research Laboratories 97

Research Laboratories Documentation Pharmaceutical Companies Pharmaceutical Companies 97

The FDA Law Blog

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

The FDA Law Blog

MAY 13, 2024

It was Congress that intervened in 2022, to mandate FDA to issue or revise its 2017 guidance on considerations for the use of RWD and RWE to support regulatory decision-making for devices to clarify its regulatory expectations. This guidance, when finalized, will replace the original version of this document finalized in 2017.

FDA 111

FDA Medical Records Documentation 111

IDStewardship

APRIL 13, 2023

09.01.01), which went live in January of 2017. 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. ” Given that we cannot be everywhere all the time, how can this be demonstrated?

Hospitals 246

Hospitals Documentation Communication Patient Care 246

European Pharmaceutical Review

DECEMBER 9, 2022

The Global Antimicrobial Resistance and Use Surveillance System (GLASS) report 2022 by the World Health Organization (WHO), which contains AMR trends for the first time since 2017, showed that common bacterial infections are becoming increasingly resistant to treatments. Data from the 2022 GLASS report.

Hospitals 98

Hospitals Documentation 98

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 90

FDA Chemotherapy Documentation 90

ISPE

SEPTEMBER 15, 2022

The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments. 12 of February 2020 again received 2,000 comments from public consultation.

Documentation 97

Documentation FDA 97

pharmaphorum

APRIL 6, 2021

A Life on Wheels started out as Ross’ hobby back in 2017 and has been growing steadily ever since. It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. A resonating hobby.

Documentation 132

Documentation 132

pharmaphorum

OCTOBER 29, 2020

By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.

Documentation 101

Documentation 101

The FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

Documentation 52

Documentation FDA 52

European Pharmaceutical Review

JUNE 12, 2024

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2017; 55(7):1998-2008. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al. Lancet Gastroenterol Hepatol. 2022; 7(12):1083-1091.

Documentation 111

Documentation Labelling Hospitals 111

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

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

Vaccines 108

Vaccines Documentation Compounding FDA 108

Pharmaceutical Technology

NOVEMBER 4, 2022

The letter reported that the UK fell from fifth place in 2017 to seventh in 2020 for the number of Phase III clinical trials initiated across the world. Furthermore, reportedly, only 68% of medicines approved by the EMA were made available in England between 2017 and 2020.

Documentation 93

Documentation Pharmaceutical Companies Pharmaceutical Companies 93

pharmaphorum

DECEMBER 28, 2022

This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control. She joined NSF in 2017.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

The Checkup by Singlecare

FEBRUARY 15, 2024

However, simply having a qualifying disability typically isn’t sufficient; the person also needs documentation from a medical professional that indicates that the service animal could improve or support his or her condition. Since January 2017, Willy (a golden retriever) has been Madison’s constant companion.

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Vaccines 98

ISPE

FEBRUARY 13, 2023

Bob also initiated an agreement under which ISPE’s Guidance Documents are made available to PIC/S and WHO inspectors, which is still in place today. Phillips Professional Achievement Award in 2017 , an award that honors an ISPE Member’s significant lifetime contribution to the industry, not just ISPE.

Documentation 98

Documentation FDA 98

The FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). By Adrienne R. Key Performance Indicators.

FDA 72

FDA Documentation Communication 72

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Some providers may require lab tests or documentation of previous weight loss efforts.

Insurance 104

Insurance Insurance Coverage FDA Documentation 104

The Checkup by Singlecare

OCTOBER 24, 2024

From 2017 to 2020, 10% of people aged 20 years and older had cholesterol levels greater than 240 mg/dL. It’s well-documented that tobacco has a very negative effect on your health. However, when there’s too much cholesterol in the body, it can build up in the bloodstream and form plaque. Quitting smoking.

Documentation 87

Documentation Dosage Hospitals 87

pharmaphorum

OCTOBER 20, 2020

Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels. In the US, the trend had already started pre-COVID-19.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

Documentation 98

Documentation FDA 98

Hospital Pharmacy Europe

NOVEMBER 23, 2023

A revised version of its 2017 statement of policy on the control of AMR, the document offers up-to-date recommendations to reflect current issues around the regulation and monitoring of antimicrobial consumption and their routes of access, as well as data availability in humans and animals.

Documentation 52

Documentation Hospitals 52

ISPE

SEPTEMBER 21, 2023

This track will delve into five important topics where you will hear from speakers who will help answer your questions and provide you with the necessary information to make confident decisions regarding any updated changes to your facility, equipment, procedures, and documents.

Documentation 98

Documentation FDA 98

PQA

NOVEMBER 26, 2024

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation. Updated August 2017. Third ed.

Patient Care 52

Patient Care Documentation Communication 52

The Checkup by Singlecare

SEPTEMBER 7, 2023

A study by the Johns Hopkins Bloomberg School of Public Health found that few health insurance plans used step therapy for opioids in 2017, which may have contributed to the opioid epidemic. However, in some cases, not requiring step therapy has led to detrimental results.

Insurance 97

Insurance Health Insurance Companies Documentation Communication 97

Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

Pharmaceutical Technology

NOVEMBER 3, 2022

According to some estimates, between 2017 and 2047, the number of individuals living with stroke will increase by 27% in the EU. In a document on the alteplase shortage, the EMA suggests the drug be used to treat patients only for approved indications and for unused stock to not be disposed.

Documentation 111

Documentation Dosage Vaccines Hospitals 111

The Checkup by Singlecare

AUGUST 20, 2024

After applying, you might need to supply verification documents to your county’s Department of Job & Family Services via fax or mail. Make sure you take all the required documents with you. Provide them with as much documentation about the issue as possible. They will have all the forms you need.

Documentation 52

Documentation Insurance 52

The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter. By McKenzie E. Cato & Allyson B.

FDA 59

FDA Documentation 59

ISPE

NOVEMBER 28, 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. Problem Identification. Root Cause Identification.

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

DECEMBER 6, 2022

He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017. When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says.

Data Entry 98

Data Entry Communication Hospitals Documentation 98

pharmaphorum

OCTOBER 11, 2022

It is subject to a two-year clinical stopping rule, as for now it remains uncertain the benefits of the regimen extend beyond that timepoint and whether continuing to give it will remain cost-effective, according to the SMC’s assessment document.

Chemotherapy 52

Chemotherapy Documentation 52

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

The FDA Law Blog

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Now, we know better.

FDA 64

FDA Packaging Documentation 64

Impact Pharmaceutical Services

APRIL 27, 2023

In addition, the OPEN Act, introduced in 2017, can extend the exclusivity period of a previously approved drug by another six months. Each component of the application must be addressed completely and provide detailed information.

Documentation 52

Documentation FDA 52