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Regulatory Developments in Ophthalmology: Applying New FDA Guidance, Part One

The Premier Consulting Blog

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers.

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Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories

PPD

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care.

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reporting continued progress towards elimination as a public health problem

The Pharma Data

Setting sights on 2030. Despite setbacks due to COVID-19, WHO will accelerate work to achieve this target by 2030. The recommended essential package of care for managing lymphoedema and hydrocele should be available in 100% of districts where people are living with these manifestations.

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Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Agency IQ

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. The report recognized the potential for an electronic format for Product Information (i.e.,

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Analysis Chemical Thank You Spurred by NRDC report, California senator proposes state ban on PFAS

Agency IQ

NANCY SKINNER has updated a bill she introduced in early January 2024 to ban the sale of intentionally added PFAS in the state after 2030. In 2019, the state began to significantly ramp up its PFAS regulation and research. Spurred by NRDC report, California senator proposes state ban on PFAS California state Sen.

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Transcending expectations for cell & gene therapy development

Drug Discovery World

The global cell and gene therapy (CGT) market reached a value of ~$4 billion in 2020 and is expected to grow to ~$34 billion by 2030 1. Complexities arise while trying to establish a standard, cost-efficient, and expert process for research and manufacturing. 1: TBRC Business Research PVTLTD. TBRCBusiness Research PVT LTD.

Therapies 130
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Scandinavia: insight into opportunities for drug discovery

Drug Discovery World

Sweden’s place in the market Scandinavia is home to some of the strongest research and development hubs, with highly respected academic institutes that are helping drive the sector forward. Sweden remains Scandinavia’s powerhouse market for pharmaceutical research and development.

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