News
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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EMA: New guide on biosimilar medicines for healthcare professionals
11.05.2017
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that
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GMP: EU GMP Non-Compliance Report might lead to FDA Import Stop in future
11.05.2017
The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would
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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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MHRA: MHRA's Interpretation of Cross Contamination & PDEs
23.03.2017
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be
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RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance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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FDA: Hypertension Indication: Drug Labeling for Cardiovascular
23.03.2017
This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling
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