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Highs and lows of drug repurposing 

Drug Discovery World

It’s why pharmaceutical companies will often spend up to 10 years and upwards of $1 billion before receiving regulatory approval for a drug. According to MarketWatch, the drug repurposing sector was thought to be worth $25,280 in 2021 and is expected to grow to $30,620 million by 2028 with a CAGR of 2.8%. Benefits and barriers .

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Article EMA Thank You British regulators tease new device regulations in informative live session

Agency IQ

British regulators tease new device regulations in informative live session This week, the British regulator MHRA offered a new peek into its planned medical device regulations. BY COREY JASEPH, MS, RAC | MAR 5, 2024 11:10 PM CST Quick background on medical device regulation in the U.K. post-market regulation here.]

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Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. Improving recycling: SB 54 contains a set of recycling targets that increase between 2028 and 2032.

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Transitioning to eCTD v4.0

The Premier Consulting Blog

offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and adapting to these improvements will be mandatory across all major regulatory authorities by 2028 (earlier, in many regions). Technical Conformance Guide HL7 Version 3 Implementation Guide: Regulated Product Submission, Release 1

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Emergent BioSolutions Announces 2021 Financial Guidance, Provides Preliminary 2020 Results

The Pharma Data

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. Other 2021 Assumptions. FOOTNOTES. (1)

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Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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Article EMA Thank You Proposal for IVDR extension also impacts MDR, EUDAMED

Agency IQ

regulators considered the highest-risk IVD devices, and these and devices for self-test by the patient required Notified Body oversight. The IVDR originally gave stakeholders 5 years to comply with the regulation (May 26, 2022). The directive used a list-based system – List A and List B outlined what E.U. Once the E.U.