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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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RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance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GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance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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FDA: Considerations in Demonstrating Interchangeability With a Reference Product
10.02.2017
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing
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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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Contract Manufacturing Arrangements for Drugs: Quality Agreements
07.12.2016
This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current
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