24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.
News in brief
- Packaging defect prompts VistaPharm oxy recall
- Drug firms would prioritize EU over smaller UK market post Brexit warns ABPI
- Pfizzles out: Pfizer pulls out of Allergan merger citing US tax clampdown
- US FDA raises concerns about Lupin's Goa plant
- Zydus Cadila given nod to export antibiotic from US FDA warned plant
24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.
23-May-2016 - French investigators reviewing the Phase I trial in which one volunteer died and five others were hospitalized in January have criticised CRO Biotrial over how it conducted the study.
19-May-2016 - Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.
17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”
13-May-2016 - Working together could save regulators millions and increase availability of medicines for patients, delegates say at the EDQM's International Generic Drug Regulators Programme (IGDRP) in Strasbourg.
News in brief
12-May-2016 - VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.
11-May-2016 - A remediation plan by Medreich Limited is sufficient to bring its Andhra Pradesh antibiotics plant in to compliance with GMP according to French regulator ANSM.
Regulatory & Safety: Featured news
Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.