Pharmafile

JANUARY 9, 2024

GSK and Aiolos Bio have announced that they have entered into an agreement for GSK to acquire Aiolos for an initial $1bn upfront payment along with up to $400m in success-based regulatory milestone payments.

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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Major differences between the Revised Draft Guidance and the Initial Draft Guidance include additional recommendations, an example of a misleading promotional communication for interchangeable biosimilar products, and clarifications on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

The FDA Law Blog

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms.

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FDA Labelling 59

European Pharmaceutical Review

APRIL 4, 2024

million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. To learn more about the impact of the initiative on the UK ATMP sector, EPR asked Barry to elaborate on how the Advanced Therapy Treatment Centre Network can support UK ATMP clinical trials.

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ISPE

SEPTEMBER 8, 2023

Most important, the lack of global regulatory harmonization reduces incentives for industry to invest in these innovations, which, in many ways, limits access of safe, effective, and quality drug products to patients globally. Representatives from regulatory authorities are also encouraged to complete the survey.

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FDA Dosage Documentation Communication 52

STAT

FEBRUARY 27, 2024

Yet these measures, according to those involved in the original FDA decision along with regulatory scholars, were originally put in place in an effort to be especially cautious, given the political controversy around the pill.

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Medical Schools FDA 132

ISPE

SEPTEMBER 15, 2023

The Regulatory, Compliance, and Quality sessions, promise to be a comprehensive exploration of the vital topics shaping the pharmaceutical landscape. However, it also poses intricate regulatory challenges, as it requires navigating a complex terrain of both pharmaceutical and medical device regulations.

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The FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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Documentation FDA 119

European Pharmaceutical Review

OCTOBER 4, 2022

The chosen organisations will be assisted through the regulatory process, from best manufacturing practice to planning regulation-approved clinical development. The chosen organisations will be assisted through the regulatory process, from best manufacturing practice to planning regulation-approved clinical development.

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Hospitals 94

Outsourcing Pharma

JANUARY 18, 2022

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.

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ISPE

SEPTEMBER 8, 2023

This article outlines these initiatives. 2023 ISPE DRUG SHORTAGES PREVENTION MODEL The 2023 ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry. and Chair of the ISPE Drug Shortages Team.

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Documentation 91

STAT

OCTOBER 11, 2023

LONDON — This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment — the latest potential turning point for a drug that has seen its share of ups and downs with regulatory bodies.

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Outsourcing Pharma

AUGUST 24, 2021

The CRO has launched an initiative that offers help navigating regulatory issues for ultra-rare disease patient advocacy groups that demonstrate a need.

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The FDA Law Blog

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Adapting to the New Regulatory Framework and Addressing Implementation Challenges.” HP&M is proud to have our professionals participating in these important events. On March 20-21, Counsel John W.M.

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European Pharmaceutical Review

MARCH 1, 2024

Its API manufacturing facilities undergo stringent inspections from regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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FDA 59

European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.

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Hospitals 94

European Pharmaceutical Review

JUNE 26, 2023

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. There were 61 RWD research opportunities identified, 30 studies initiated and 27 completed in this period. Four studies were initiated via DARWIN EU ®.

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Medical Records Clinic Management 84

European Pharmaceutical Review

MARCH 24, 2023

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Initially published in March 2020, the strategy provides a plan for advancing regulatory science over a five-year period.

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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

MARCH 22, 2023

Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. Previous winners include a who’s who of pharma manufacturing CEOs from Piramal and WuXi AppTec to Catalent and last year’s winner Aragen Life Sciences.

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Packaging 98

European Pharmaceutical Review

DECEMBER 19, 2023

Ionis will be responsible for non-clinical and clinical development of donidalorsen, Otsuka will apply for regulatory approval and commercialise the drug in Europe. “We He added that agreement is aligned with Ionis’ strategy to “initially focus commercialisation efforts on the US market.”

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Labelling 99

European Pharmaceutical Review

MARCH 12, 2024

Joseph S Boakai (JSB): The three current trends are as follows: Increased scrutiny by regulatory bodies. Ensuring data integrity in the life science industry is crucial for regulatory compliance. What is the biggest impact of having compromised data when working with regulatory bodies in the pharmaceutical industry?

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STAT

MAY 24, 2023

Ltd, required global regulatory approvals that we were not able to obtain in some countries,” said Boston Scientific spokesperson Kate Haranis. “Our agreement to purchase the majority stake of M.I.Tech Co., Ltd, from Synergy Innovation Co.,

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Hospital Pharmacy Europe

OCTOBER 30, 2023

The solidarity mechanism and MSSG Toolkit form part of a wider European Commission (EC) initiative to protect Europe against medicines shortages this winter and in the future through a set of coordinated actions. A Critical Medicines Alliance will be operational in early 2024 and will coordinate mid-term and long-term measures, the EC said.

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European Pharmaceutical Review

DECEMBER 19, 2023

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

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Packaging Documentation 97

The FDA Law Blog

OCTOBER 16, 2022

James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure. (HP&M) is pleased to announce that James E. Valentine will become the firm’s newest Director beginning on January 1, 2023. His full bio can be found here.

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Pharmaceutical Commerce

MARCH 6, 2023

Initiative intends to facilitate regulatory compliance within the pharma distribution space.

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Vaccines 52

ISPE

NOVEMBER 23, 2022

The keynote speaker, Emer Cooke, Executive Director of the European Medicines Agency (EMA) and Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), addressed the Symposium on how to strive for better international relationships and collaboration.

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Documentation FDA Communication 98

STAT

APRIL 10, 2023

government regulatory authority that could go far beyond one drug , The New York Times explains. The initial ruling could open the door to lawsuits to contest approvals or regulatory decisions related to other medications. Food and Drug Administration approval of the abortion pill mifepristone poses threats to U.S.

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FDA 92

European Pharmaceutical Review

JANUARY 4, 2024

concluded that updating regulatory guidelines and developing relevant standards and guidelines to accommodate the development of these systems “are essential to reduce the associated costs and allow off-the-shelf solutions to be developed.” Borgosz et al. To facilitate the adoption of IIoT systems in bioprocessing, Borgosz et al.

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European Pharmaceutical Review

AUGUST 3, 2022

The ideas and proposals put forward on this topic during the recent EDQM Symposium on Nanomedicines will be taken into account during the process, as will the experience gained with these vaccines during the COVID-19 pandemic, in which mRNA vaccines garnered regulatory approval for the first time.

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Vaccines 98

European Pharmaceutical Review

APRIL 16, 2024

Initiation of the licensing agreement will help Teva to grow its biosimilar pipeline. Based on the agreement, Teva stated that by leading the regulatory processes and commercialisation in planned regions, the company will facilitate broader access of the biosimilar to eligible patients.

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ISPE

FEBRUARY 13, 2023

After retiring from TGA Bob remained an active consultant, guiding many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Most recently he assisted the regulatory authorities of Saudi Arabia, Russia, China, Jordan, and Philippines in the process to attain PIC/S membership.

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Documentation FDA 98

The Checkup by Singlecare

DECEMBER 1, 2022

Regulatory affairs, however, encompasses more than just the pharmaceutical industry. Due to the variety of industries that need assistance with regulatory affairs, many people who work in regulatory affairs come with advanced degrees from different backgrounds, such as public health policy, biomedical engineering, and nutritional sciences. .

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Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 98

The FDA Law Blog

OCTOBER 24, 2022

The Federal Register notice states that the Advancing RWE Program “seeks to identify approaches for generating RWE that meet the regulatory requirements in support of labeling for effectiveness ( e.g. , new indications, populations, dosing information) or for meeting post-approval study requirements.”

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FDA Labelling 78

Impact Pharmaceutical Services

SEPTEMBER 28, 2023

The FDA processes around 1,500 initial IND applications annually and assesses them primarily to safeguard the safety of study participants, but also to ensure properly designed and conducted clinical trials. Other IND subclasses exist, too.

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Documentation FDA Packaging 59

European Pharmaceutical Review

AUGUST 8, 2023

It is also indicated to treat obese paediatric patients over 12 years old with an initial BMI at the 95th percentile or greater for age and gender. Novo Nordisk has stated it expects to file for a regulatory label indication expansion for the treatment in the US and the EU in 2023.

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Labelling 98