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

pharmaphorum

SEPTEMBER 28, 2022

The nine-company pilot launched in 2017 and is designed to explore a new approach to regulating digital health, based on certifying companies and their internal processes rather than individual devices and apps. The Pre-Cert pilot report. O’Leary said.

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FDA Documentation 135

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.

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FDA Medical Records Documentation 109

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.

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Controlled Substances Documentation Dosage Prescription Filling 139

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.

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Hospitals Documentation 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

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.

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Documentation Insurance 52

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.

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Documentation Dosage Hospitals 87

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.

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Documentation FDA 97

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.

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Documentation Labelling Hospitals 111

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.

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FDA Chemotherapy Documentation 75

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.

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Chemotherapy Packaging FDA Documentation 52

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.

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FDA Documentation Communication 105

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.

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FDA Documentation Communication 70

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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 93

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.

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Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

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

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?

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Hospitals Documentation Communication Patient Care 246

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

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

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

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.

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Documentation 100

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

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

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.

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FDA Documentation 57

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.

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Insurance Insurance Coverage FDA Documentation 104

ISPE

OCTOBER 28, 2022

In 2017, the European Pharmacopoeia joined the US, Japan, and many other regulatory bodies (with the exception of China) in accepting mem-brane-based technologies for WFI production. Tell us about your role at ISPE: What do you do each day?

Documentation 52

Documentation 52

ISPE

MAY 9, 2023

In 2017, we organized our first Hackathon. Elevating education is also crucial for societal progress, with ISPE’s new Technology Without Borders initiative, knowledge documents, and trainings being made available in the areas of the world where there’s a need.

Documentation 52

Documentation 52

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.

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FDA Packaging Documentation 62

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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 117

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

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

The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. Communities in Action: Pathways to Health Equity (2017) Time to take stock: a meta-analysis and systematic review of analgesic treatment disparities for pain in the United States. A long history of medical racism in the U.S.

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Insurance Coverage Communication Documentation Compounding 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.

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Insurance Health Insurance Companies Documentation Communication 97

The Checkup by Singlecare

OCTOBER 9, 2024

Its first approval was in 2017 for atopic dermatitis (eczema). Prior authorization might require the healthcare provider to submit documentation of your symptoms, diagnosis, specialist visits, or other information. More than 800,000 people around the world take Dupixent because it’s so effective.

Insurance 52

Insurance Labelling Insurance Coverage Specialty Pharmacies 52

PQA

NOVEMBER 20, 2023

Ultimately, these measures aim to reduce the use of these combinations of medications in the older adult population, for which serious safety concerns have been documented. Continued support and use of the POLY-ACH and POLY-CNS measures has grown over the years since their endorsement by PQA’s membership in 2017.

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Documentation 52

The FDA Law Blog

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. Would there be a new regulatory framework, as is proposed in VALID and outlined in FDA’s 2017 discussion paper (see our prior post here ), or something different? See , e.g. , ACLA White Paper on LDTs here.

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FDA Documentation 54