SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulatory & Safety: Top Headlines

News in brief

Recipharm will serialize customers' drugs for free until US and EU rules come into force

24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.

update

Biotrial criticised over fatal Phase I study by France's social affairs inspectorate

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.

Exclusive interview

Clinical Trials Day: focusing on awareness, the ‘war on talent,’ and an industry-wide commitment

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.

MPA withdraws Bend's Oregon plant GMP certificate citing deficiencies

17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”

Live from EDQM: Regulators say quality will drive generics availability

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

Packaging defect prompts VistaPharm oxy recall

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.

ANSM says Medreich plan will bring non-compliant Bollaram plant up to code

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

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...