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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

What will the orphan drug market exclusivity haircut mean for industry? Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Orphan designation in the E.U.

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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. IVDR designations continues to lag behind MDR designations, as noted above.

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Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

The Pharma Data

Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. SARS-CoV-2 Rapid Antigen Test package insert [2] European Centre for Disease Prevention and Control. Food and Drug Administration (FDA).

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Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

These standards were expected to be established within 30 months, or by March 27, 2010. In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations. submitted the results of their own market research study on a fictitious drug. Interestingly, Merck & Co.

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Article Periodic Thank You E.U. chemical developments we’re expecting in October 2023

Agency IQ

On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). food packaging, kitchen and tableware and food processing equipment).

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Article Periodic Thank You What we expect EU regulators to do in February 2024

Agency IQ

One consultation closes on February 1 on an amendment to Directive 2010/63/EU on the protection of animals used for scientific purposes , updating standards on care, accommodation and killing. food packaging, kitchen and tableware and food processing equipment). EU food safety policy includes rules on food contact materials (e.g.,

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Analysis Chemical Thank You Regulatory roundup: EU active on PFAS as Q4 commences

Agency IQ

Codes starting with 3 are for facilities conducting activities covered by the EU’s Industrial Emissions Directive (EU) 2010/75 (IED), and codes starting with 4 are for facilities with substances covered by the Seveso III Directive 2012/18/EU. Codes beginning with 1 categorize facilities based on the substances used there (i.e.,