news
FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
List view / Grid view
QA/QC
news
US and India receive most warning letters from FDA
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
news
Emcure Pharmaceuticals receives warning letter from FDA
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
article
Cannabinoids in pharma series: the challenges of working with cannabinoids
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this second piece, we discuss the challenges, legal implications and perceptions of cannabinoids.
news
Complete response letter handed to Sarepta Therapeutics
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
news
MHRA consultation on application of AQbD principles enters last month
An MHRA consultation is due to end on 31 August, with public comments on AQbD principles closing soon.
article
Cannabinoids in pharma series: cannabinoids on the market today
This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.
news
Letter highlights issues with US drug returns verification requirements
An open letter has underscored the challenges of return failure in the US drug supply chain, especially after the introduction of the Drug Supply Chain Security Act in November.
whitepaper
Application note: Cell-Based Therapies – Be on the Safe Side
Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment.
whitepaper
Whitepaper: USP <797> Revisions and Impact
The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements.
webinar
Accelerate food, pharmaceutical and particle analysis with Raman imaging
7 August 2019 | By WITec GmbH
This webinar describes how Raman microscopy can help solve some of the most vital and challenging questions that researchers face in 3D imaging and microparticle analyses of food, pharmaceuticals and microplastics, along with providing measurement examples from each field.
whitepaper
Whitepaper: Recent advances in pharmaceutical regulations for viable environmental monitoring
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
article
Climate change: how pharma will profit from a warming planet
Rising temperatures will likely accelerate the spread of vector-borne diseases, resulting in an increased demand for vaccines. European Pharmaceutical Review investigates a Morgan Stanley report on the pharmaceutical beneficiaries of climate change.
news
Tecan Synergence™ offers comprehensive approach to OEM system development
Tecan Partnering has consolidated its extensive OEM system development services for life sciences and IVD instruments to create Tecan Synergence™.
article
Surge in negative verifications of saleable returns could cost pharma industry billions
The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.
