pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. It has drawn up the guidance with the help of the companies, the ABPI, and UK regulator the MHRA.

Communication 105

Communication Documentation 105

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Documentation 64

Documentation FDA 64

ISPE

FEBRUARY 14, 2023

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. After a thorough internal review, health authorities sometime release a document for public comment. What is Commenting? Know the key topics.

Documentation 52

Documentation Communication 52

ISPE

SEPTEMBER 14, 2023

Wager 14 September 2023 With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents.

Documentation 98

Documentation 98

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Documentation 100

Documentation 100

Hospital Pharmacy Europe

APRIL 25, 2024

A patient safety culture The updated standards also reflect new frameworks and guidance that have been released by NHS England and the DHSC since 2016. Specific guidance on what being ‘open and honest’ looks like is included within the standards, as well as the need for workplaces to create and promote ‘a just culture’.

Community Pharmacies 52

Community Pharmacies Hospitals Documentation 52

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 108

FDA Documentation Vaccines 108

Hospital Pharmacy Europe

AUGUST 17, 2023

Guidance on the provision of CAR T and cellular therapy services in hospital pharmacy has been published by the GoCART Coalition to harmonise implementation across Europe. 11 Many documents and checklists detail every stage of the pathway in preparing CAR T. The guidance is divided into two sections.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

pharmaphorum

MAY 25, 2022

But new joint guidance, from the IFPMA, EFPIA, and PhRMA, provides clarity. Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. The codes still apply.

Documentation 105

Documentation Communication Labelling 105

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

FDA 45

FDA Documentation Communication 45

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. There is an unmet need for guidance to promote the unique benefits of RCTs across all contexts and which focuses on the unique strengths of randomisation.”.

Documentation 105

Documentation Communication 105

pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders. Draft Guidance. Public Comments.

Labelling 52

Labelling FDA Documentation 52

The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

FDA 59

FDA Documentation 59

The FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. We previously blogged on the draft guidance here. By Philip Won & McKenzie E.

Documentation 45

Documentation FDA Patient Care Hospitals 45

pharmaphorum

NOVEMBER 16, 2022

NICE has recommended that three COVID-19 therapies can continue to be used to treat patients – Pfizer’s Paxlovid, Roche’s RoActemra and Eli Lilly’s Olumiant – but turned down another five in draft guidance published this week. In England and Wales, those will be superseded by NICE once the draft guidance is finalised.

Vaccines 104

Vaccines Documentation 104

IDStewardship

OCTOBER 28, 2022

Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts. Did a current or past resident’s project get accepted for publication? Part of using Twitter is keeping up with the latest trends.

Documentation 229

Documentation 229

The FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. The Guidance distinguishes between the PSG teleconference and the PSG meeting.

FDA 59

FDA Packaging Documentation 59

Hospital Pharmacy Europe

DECEMBER 11, 2023

The UK‘s Department of Health and Social Care (DHSC) has conceded that there is a potential risk to patient safety with its proposed changes to supervision legislation, which are currently under public consultation. A version of this article was originally published by our sister publication The Pharmacist.

Hospitals 52

Hospitals Documentation 52

pharmaphorum

SEPTEMBER 30, 2021

There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken. The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

FDA 95

FDA Documentation Insurance 95

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 80

Adverse Reactions Documentation Medical Schools Packaging 80

ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

European Pharmaceutical Review

DECEMBER 16, 2022

The document includes all current recommendations on treatment of DR-TB and is supplemented by an operational handbook designed to aid the implementation of WHO recommendations by Member States, technical partners and those involved in the management of patients with DR-TB. Who can utilise the World Health Organization’s 2022 update?

Documentation 91

Documentation 91

pharmaphorum

JANUARY 14, 2022

The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.

Documentation 126

Documentation 126

The FDA Law Blog

SEPTEMBER 6, 2023

As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

FDA 45

FDA Packaging Documentation Labelling 45

Omnicell

JANUARY 10, 2023

Ted Slafsky Founder and Principal, Wexford Solutions, and Publisher and CEO, 340B Report Since its inception in 1992, the 340B program has largely been governed by federal guidance, rather than regulations, u ntil the Affordable Care Act (ACA). In fact, every aspect of the 340B program was interpreted through guidance.

Documentation 52

Documentation Hospitals 52

ISPE

NOVEMBER 23, 2022

Prepare GMP Inspectorates for the future by equipping inspectors with skills and training to inspect new technologies, ensuring that GxP standard guidance is not an obstacle to the development of new technologies. He indicated that PIC/S participates in the ICH Q12 implementation Working Group.

Documentation 98

Documentation FDA Communication 98

pharmaphorum

JULY 14, 2022

Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Full list: [link].

Documentation 52

Documentation Vaccines 52

The FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

FDA 52

FDA Documentation 52

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. A version of this article was originally published by our sister publication The Pharmacist.

Hospitals 52

Hospitals Community Pharmacies Documentation Communication 52

The FDA Law Blog

NOVEMBER 2, 2023

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.” It finalized a draft guidance published in 2022.

FDA 59

FDA Packaging Documentation Labelling 59

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

Omnicell

JANUARY 10, 2023

Bill helped draft the original law and has played a crucial role in shaping all the additional 340B legislation, regulations, and guidance that have been enacted since then. 20 key moments that have shaped the 340B program: 1992: Section 340B of the Public Health Service Act is signed into law by President H.W. Bush on November 4.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

The FDA Law Blog

FEBRUARY 15, 2023

FDA also noted that some of the recommended protections are outdated and redundant to Federal and State requirements, such as professional guidelines, current radiation guidance documents and industry standards that practitioners and industry rely on to ensure public health and safety.

FDA 52

FDA Documentation 52

ISPE

SEPTEMBER 8, 2023

The document is based on a number of reports from the EU Commission and aims to ensure citizens’ trust in AI systems. The GAMP guidance may potentially prove useful for other areas and industries in supporting the quality assurance activities and methods described in the draft regulation, at the discretion of the organizations involved.

Documentation 52

Documentation 52

The FDA Law Blog

SEPTEMBER 6, 2022

Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance). This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).

FDA 52

FDA Documentation Labelling 52

pharmaphorum

DECEMBER 30, 2022

The report also finds that the joint briefing document presented to the advisory committee did not adequately represent differing views within the FDA on Aduhelm. Biogen’s hopes were for sales of around $18 billion per year from Aduhelm, says the document, without consideration of the impact that could have on the US healthcare system.

FDA 58

FDA Documentation Labelling 58