The FDA Law Blog

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken.

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FDA Documentation Labelling 67

European Pharmaceutical Review

FEBRUARY 1, 2024

For at least a decade from 2013 until recently, LDL lowering treatments were stuck on a paradigm of just putting people on statins and not getting LDL levels down to certain goals” CETP inhibitors have been around for a while, but they have unfortunately been unsuccessful in getting onto the market commercially. “For

Documentation 97

Documentation Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

DECEMBER 29, 2022

The FDA granted full approval to Par’s generic on 28 March, 2013. According to court documents cited by Reuters, annual sales of Exforge in the US were over $400 million before generic versions reached the market.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

pharmaphorum

MARCH 5, 2021

billion in annual sales it generated during its peak year in 2013. Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing a long-acting version to counter cheaper copycat drugs.

Documentation 98

Documentation Communication Hospitals 98

pharmaphorum

MARCH 7, 2022

In a letter to the BMJ, Kingsley Manning – who headed NHS Digital between 2013 and 2016 – said that the move is a “grave error” that could threaten the confidentiality and use of patient data. ” “NHS Digital was established to provide at least element of protection,” writes Manning.

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Documentation 115

pharmaphorum

AUGUST 23, 2021

The debacle conjures up the spectre of the government’s last attempt to shake up patient data-sharing – 2013’s Care.data scheme – which suffered from a number of false starts and was eventually shut down in 2016. survey conducted in July. ” The post NHS data sharing scheme “on hold” as millions opt out appeared first on.

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Medical Records Documentation Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

FEBRUARY 25, 2021

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

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Documentation Labelling 111

Druggist

MAY 6, 2021

The official guide on type-2 diabetes management: document produced by NICE for healthcare professionals in the UK, which recommends treatment for type-2 diabetes. . cells (Weir GC, Bonner-Weir, 2013). As the above document suggests, the evidence for increased risk of cancer came firstly from animal studies. Epub 2013 Jan 30.

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Documentation 98

pharmaphorum

JULY 16, 2021

Advisory committee members were mainly concerned about the safety profile of roxadustat, an oral HIF-PHI drug, including its potential to cause serious thromboembolic events which were flagged by the FDA in a briefing document published ahead of the meeting.

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FDA Documentation 52

DiversifyRx

NOVEMBER 24, 2023

Exploring the Drug Supply Chain Security Act (DSCSA) The DSCSA, signed into law in 2013, aims to heighten the security of the pharmaceutical supply chain by creating a framework for traceability and accountability. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

PQA

JUNE 16, 2023

Since 2013, BCHC and UKCOP have collaborated to offer clinical pharmacy services. The partnership ensures that underserved and vulnerable community members receive appropriate, compassionate care, including equitable and affordable medication access. data sources), and usability.

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Documentation Vaccines 40

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed.

FDA 40

FDA Packaging Documentation 40

pharmaphorum

JANUARY 12, 2023

From the period of 2013 until the present, a third wave of the crisis struck, which saw synthetic opioids, such as fentanyl, cause a greater number of deaths. As the crisis rumbles on, there is a risk of greater levels of drug diversion, which requires a counter strategy on the part of the healthcare care industry and regulators.

Hospitals 105

Hospitals Documentation 105

pharmaphorum

SEPTEMBER 16, 2021

Since their inception in 2013, Clinical Commissioning Groups (CCGs) have led medicines optimisation efforts at local level. The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. A changing healthcare landscape.

Community Pharmacies 113

Community Pharmacies Patient Care Medical Records Documentation 113

pharmaphorum

OCTOBER 7, 2020

When I finally sought treatment in 2013, I learned how to turn my ADHD into a strength by better managing it. Done is here to combat these stereotypes, and is working to remove barriers to treatment such as requirements and expectations about frequency of visits, documentation, medication choice and choice of provider.

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Documentation Patient Care 76

The FDA Law Blog

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. Most of the compliance dates have been passed.

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Packaging Labelling FDA Documentation 44

PQA

AUGUST 8, 2022

The History Pharmacy Quality Solutions has hosted performance data on medication-related quality measures in the EQUIPP® platform since 2013. The views shared in this series are those of the author and do not reflect any PQA positions.

Independent Pharmacies 52

Independent Pharmacies Community Pharmacies Patient Care Vaccines 52

The Checkup by Singlecare

FEBRUARY 28, 2024

Illinois is one of the many states that opted to expand Medicaid coverage under the 2013 Affordable Care Act (ACA). It now covers more than 3.9 million Illinoisans as of November 2023. However, if you’re not interested in applying for those benefits, you can simply leave their respective sections of the application blank.

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Nursing Homes Insurance Documentation Assisted Living 52

Pharmaceutical Technology

OCTOBER 5, 2022

These, along with other similar claims, meant Biogen owed potential damages of $1,036,900,151 to the US and the various States, as per court documents. Tecfidera was approved in 2013 to treat MS, and in August 2020, Mylan launched its first FDA-approved dimethyl fumarate generic to the market.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

Pharmaceutical Technology

NOVEMBER 4, 2022

At the time of its publication, the document prioritised the finalisation of Brexit above all else. The SME R&D tax credit scheme allows tax relief of up to 33% on qualifying R&D expenditure, which the former PM David Cameron’s cabinet introduced in April 2013. says O’Meara.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 93

pharmaphorum

SEPTEMBER 29, 2022

In the United States, the Food and Drug Administrator (FDA) has so far published three draft guidance documents on patient-focused drug development, with a fourth expected in the coming months. Previously, Mathieu worked for EURORDIS-Rare Diseases Europe since 2013, involved in activities to foster the access to innovation to patients.

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Documentation FDA 98

The People's Pharmacy

MAY 8, 2023

There have been problems with records in the past: deceit, falsification of documents and even outright fraud. Since the start of 2013, pharmaceutical companies based in the U.S. We know from investigating the FDA’s approval process ourselves that the honor system does not work.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. Medical Care Research and Review (2013) Racial and Ethnic Disparities in Health Insurance Coverage: Dynamics of Gaining and Losing Coverage over the Life-Course. A long history of medical racism in the U.S.

Insurance Coverage 52

Insurance Coverage Communication Documentation Compounding 52

The Checkup by Singlecare

DECEMBER 1, 2023

Sources Photostability of organic red food dyes , Food Chemistry (2020) Certified food dyes in over-the-counter medicines and supplements marketed for children and pregnant women , Food and Chemical Toxicology (2020) Color additives questions and answers for consumers , FDA (2018) Background document for the Food Advisory Committee: Certified color (..)

Labelling 52

Labelling FDA Documentation 52

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. 2011;29:7122–7124. Sharma D, Khamar S, Cullen A, et al.

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Vaccines Communication Immunization Documentation 111

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey as the Senior Principal Scientist in early phase drug development. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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Vaccines FDA Research Laboratories Documentation 128

The Spirit Pharmacist

FEBRUARY 21, 2023

There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23]. J Psychoactive Drugs, 2013. Nevertheless, several case reports of ophthalmic or limb abnormalities born to mothers who used LSD exist in medical literature [19-22].

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Documentation Compounding Immunization FDA 98

The Digital Apothecary

MAY 11, 2018

I had started being an Assistant Professor in January of 2013. My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. The First Year (January - June, 2013) So my first academic year started mid-cycle.

Documentation 52

Documentation Hospitals Patient Care 52

The Checkup by Singlecare

JANUARY 18, 2024

Because numerous possible reasons could be linked to postprandial sleepiness, keeping a food journal to document these important clues on how your food affects you could be helpful. appeared first on The Checkup.

Medical Schools 52

Medical Schools Mayo Clinic Labelling Documentation 52

European Pharmaceutical Review

SEPTEMBER 22, 2022

2013 Oct; 48(10): 943–953. Published online 2013 Jul 2. NICE DSU technical support document 18: methods for population-adjusted indirect comparisons in submissions to NICE. Mayer-Hamblett N, Rosenfeld M, Treggiari MM et al. Standard Care versus Protocol Based Therapy for New Onset Pseudomonas aeruginosa in Cystic Fibrosis.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

ISPE

MARCH 9, 2023

To estimate the infiltrated door flows, design documentation can be used. 4 (2013): 1437–1471. Specifically, the differential pressure (dp) between rooms should be known from the pressurization plan, and design drawings can be used to estimate the flow area of the door clearance (gap between door edge and floor or door edge and wall).

Documentation 52

Documentation Communication 52

The Thyroid Pharmacist

DECEMBER 7, 2022

The PBDEs consisted of several commercial mixtures known as octa-BDE, penta-BDE, and deca-BDE (all phased out by 2013 in the U.S.; Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. 2013 Aug;26(4):498-510; Chevrier J, Harley KG, Bradman A, et al. Curr Opin Pharmacol.

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Health and Personal Care Stores Labelling Immunization Compounding 71

pharmaphorum

MAY 14, 2021

For example, its 2013 guide to the methods of technology appraisal is still a valid reference to understand the key principles of cost effectiveness within an HTA context, and NICE decision support unit documents are a useful resource for any health economist needing technical or educational support.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 59

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

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FDA Documentation Labelling 57

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 47 (18 November 2013): 12359–63. Angewandte Chemie International Edition in English 52, no.

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Chemotherapy Documentation Dosage Labelling 52

The Thyroid Pharmacist

DECEMBER 1, 2023

In fact, researchers behind a 2013 meta-analysis observed that, statistically, people with low vitamin D were at a much greater risk of depression. [6] Vitamin D deficiency has been documented in Hashimoto’s, Graves’ disease, thyroid cancer, as well as postpartum thyroiditis. [13]

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Immunization Documentation Dosage 97