News
RAPS: FDA Offers its Views on Medical Device Trials
11.05.2017
Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide array
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RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition
11.05.2017
A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The
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RAPS: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)
11.05.2017
EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The ...
GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC
11.05.2017
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of
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RAPS: UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA
23.03.2017
The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in
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RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance
23.03.2017
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance
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RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India
23.03.2017
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis
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RAPS: CDRH Warns Three Foreign Medical Device Manufacturers
10.02.2017
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China
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RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
05.01.2017
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is
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RAPS: FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions
05.01.2017
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations.
The US Food
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