The FDA Law Blog

APRIL 25, 2024

Major differences between the Revised Draft Guidance and the Initial Draft Guidance include additional recommendations, an example of a misleading promotional communication for interchangeable biosimilar products, and clarifications on postmarketing reporting requirements. l)(1) (e.g.,

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Labelling Communication FDA 59

European Pharmaceutical Review

APRIL 4, 2024

million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.

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PQA

FEBRUARY 23, 2024

This public webinar will review a draft call to action to advance the quality of MTM services, following the December 11-January 12 public comment period. PQA staff will review the comments received and the work to finalize the call to action. See our blog for more details on this initiative, and register to join us for the webinar.

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Hospitals 52

The FDA Law Blog

SEPTEMBER 29, 2023

The proposed rule has a 60-day comment period for stakeholders. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs. This proposed rule is a long-time coming.

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FDA 59

European Pharmaceutical Review

OCTOBER 5, 2023

With 20 years of leadership experience in the life sciences and biopharma sector, Pedersen has previously had senior leadership positions in quality assurance (QA) and quality control ( QC ), regulatory affairs as well as external manufacturing.

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ISPE

MAY 22, 2023

Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Hustead Executive Director, Regulatory Affairs Merck & Co.,

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Communication FDA 98

European Pharmaceutical Review

DECEMBER 5, 2023

The programme is the EU’s key funding initiative for research and innovation with a budget of €95.5 Now, this final step in the process has been implemented by the EU-UK Specialised Committee on Participation in Union Programmes (SCPUP), the European Commission (EC) has announced. billion for 2021-27.

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European Pharmaceutical Review

JULY 21, 2023

The document is part of the joint Heads of Medicines Agencies (HMA)-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation. AI brings exciting opportunities to generate new insights and improve processes.

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Documentation FDA 77

European Pharmaceutical Review

JANUARY 15, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree ® (vamorolone), as a safer alternative to corticosteroids, for Duchenne muscular dystrophy (DMD). “In Initial European launch will be in Germany in Q1,” Dr Hasham confirmed.

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Hospital Pharmacy Europe

JANUARY 18, 2024

In August 2023, the NHS in England became the first health system in the world to roll out SC atezolizumab after its approval by the Medicines and Healthcare products Regulatory Agency (MHRA). The post European approval of SC atezolizumab offers quicker and more flexible cancer treatment appeared first on Hospital Pharmacy Europe.

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Hospitals 101

European Pharmaceutical Review

APRIL 18, 2023

This proposed acquisition builds on our expertise in respiratory therapies,” commented Luke Miels, Chief Commercial Officer at GSK. Based on this data, the CALM Phase III programme, consisting of the CALM-1 and CALM-2 trials, was initiated. Camlipixant is anticipated to gain regulatory approval and be launched in 2026.

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European Pharmaceutical Review

NOVEMBER 18, 2022

It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. The most common side effects observed were initial insomnia, irritability and dyskinesia. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over.

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European Pharmaceutical Review

JUNE 26, 2023

Dr Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research stated the regulatory body “hopes to outline the challenges inherent in designing psychedelic drug development programmes” and provide potential solutions. However, these are still investigational products.

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The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). Any comments to the public notice must be submitted by August 11, 2023. This statistic is quite disheartening.

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FDA Documentation Labelling Communication 59

European Pharmaceutical Review

MAY 11, 2023

The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion. The questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development.

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FDA Communication 79

pharmaphorum

JANUARY 8, 2021

The use of real-world evidence (RWE) has grown rapidly in pharma over the last few years, as healthcare payers and regulatory agencies have tried to get a deeper understanding of the impact medicinal products have in actual practice, rather than just within clinical trial settings.

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European Pharmaceutical Review

MARCH 17, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) ’s UK Stem Cell Bank is trialling an innovative new robot that grows stem cells. The UK is only the second country where this technology has been tested,” Health and Social Care Secretary Steve Barclay commented.

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European Pharmaceutical Review

NOVEMBER 2, 2023

To facilitate this initiative, the European Pharmacopoeia Commission (EPC) declared that it is looking for experts. On 24 October, Medicines for Europe commented the Commission’s actions. They could provide a temporary replacement for potentially unavailable, essential licensed medicines, the EDQM explained in its statement.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months.

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European Pharmaceutical Review

OCTOBER 21, 2022

Under the deal, Gilead will pay MacroGenics an initial $60 million. billion in target nomination, option fees and development, regulatory and commercial milestones related to developing treatments for cancers such as acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). MacroGenics will be entitled up to $1.7

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ISPE

JUNE 27, 2023

The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA). As Rosa commented “be prepared to teach us”.

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Communication FDA Vaccines 52

European Pharmaceutical Review

OCTOBER 17, 2022

These initiatives aim to allow medicinal products that address unmet medical needs to be accessed more quickly worldwide. The schemes also avert regulatory intervention, which can slow down the drug accessibility process. Today, people in over 100 countries are affected by the condition.

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Vaccines 86

European Pharmaceutical Review

NOVEMBER 29, 2022

Carsten Linnemann, PhD, Chief Executive Officer at Neogene commented: “We are excited to work together with AstraZeneca towards transforming the treatment options for patients with solid tumours using next-generation T-cell receptor therapies… for hard-to-treat cancers.”.

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Immunization 85

pharmaphorum

OCTOBER 27, 2022

These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. Companies should monitor, moderate and, where appropriate, delete inappropriate comments in a timely manner. What is the scope of the Guidance?

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ISPE

NOVEMBER 22, 2022

ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections. ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections. The 2022 ISPE Singapore Affiliate Conference & Exhibition featured a regulatory roundtable discussion on the Future of Pharmaceutical Inspections. AP Regulatory Affairs Advisor.

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FDA Documentation Vaccines 52

The FDA Law Blog

MAY 15, 2023

In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. As part of its regulatory responsibilities, CVM reviews the safety of new or modified animal food ingredients. In addition, CVM, on its own initiative, may propose an animal food additive or color additive regulation.

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Labelling Documentation FDA 45

European Pharmaceutical Review

JANUARY 24, 2023

HUTCHMED will receive $400 million upfront as well as up to $730 million on meeting regulatory, development and commercial sales milestones. Regulatory applications for fruquintinib Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018. The agreement is valued up to $1.13

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FDA 52

ISPE

OCTOBER 28, 2022

The regulatory frameworks for these products vary from country to country. In the US, each constituent part retains its regulatory identity in a combination product. Communities of Practice Development. “I I became active in the combination products space during my 26-year career with Johnson & Johnson,” Neadle said.

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FDA 52

The FDA Law Blog

MAY 10, 2023

This much welcomed — and needed — extension of the telemedicine flexibilities is a result of DEA’s receipt of over 38,000 comments on its set of proposed telemedicine rules for controlled substances and for buprenorphine treatment. More specifically, the temporary rule adds new regulatory sections 21 C.F.R. 1307.41and 42 C.F.R.

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Controlled Substances Communication 52

Hospital Pharmacy Europe

SEPTEMBER 1, 2023

The subcutaneous anti-PD-L1 cancer immunotherapy atezolizumab (brand name Tecentriq subcutaneous (SC)) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), paving the way for its use in the NHS in England, its manufacturer Roche has announced.

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Hospital Pharmacy Europe

MAY 25, 2023

A genetic ‘biobank’ will be launched on 1 June 2023 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to understand how a patient’s genetic make up can impact the safety of their medicines. Initial research findings are due to be published in 2025.

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Hospital Pharmacy Europe

AUGUST 10, 2023

Semaglutide and MACE SELECT enrolled 17,604 adults across 41 countries at more than 800 investigator sites and was initiated in 2018. Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4 Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4

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Labelling Hospitals 98

The FDA Law Blog

JUNE 19, 2023

Once the NPRM is published, the public will have the opportunity to submit comments; given the wide range of stakeholders that would foreseeably be affected by FDA oversight of LDTs, the docket will no doubt be voluminous. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn.

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FDA Documentation 56

pharmaphorum

SEPTEMBER 7, 2020

Having started out working as a pharmaceutical sales representative 26 years ago, he has been specializing in the regulatory and clinical software solutions and services market for the past decade. Warren Stacey, SVP of Sales at PRISYM ID, commented: “Robert Bowdish is a fantastic addition to our team at PRISYM ID.

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Labelling 52

Hospital Pharmacy Europe

NOVEMBER 17, 2023

The licence of the cystic fibrosis (CF) medicines ivacaftor-tezacaftor-elexacaftor (Kaftrio) and ivacaftor (Kalydeco) have been extended by the Medicines and Healthcare products Regulatory Agency (MHRA) to include children aged two to five years old. So they are not recommended’.

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Hospitals 59

pharmaphorum

APRIL 28, 2021

Speakers at the 24 May 2021 event entitled ‘True Validation Ready Labeling – What it Really Means’ include Phil Dray, Test Manager at PRISYM ID, and two further independent experts who have long experience in cloud-based systems and regulatory compliance. . . Yet no matter the size of company, the principles of validation are the same.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

DECEMBER 22, 2022

Lilly has already decided to hold off a potential regulatory filing for the drug until it has data from a phase 3 trial. ICER, meanwhile, is accepting comments on its draft report until 2 February, with an updated version due early the following month. rate of amyloid related imaging abnormalities (ARIA).

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FDA 78