Regulatory Beat - BioPharm International


Regulatory Beat

FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B

October 30, 2014

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

Industry Stakeholders Tackle the Use of Biological Qualifiers at WHO Naming Session

October 16, 2014

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

Biopharma Manufacturers Respond to Ebola Crisis

October 1, 2014

Demand for new therapies and vaccines spotlights production challenges.

Data Integrity Key to GMP Compliance

September 1, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

Extending the Scope of Pharmacovigilance Comes at a Price

September 1, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Changes and Challenges for Generic Drugs

August 1, 2014

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

July 1, 2014

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

EU Steps Up Inspection Efforts

May 2, 2014

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Demand for New Vaccines Spurs Innovation

May 1, 2014

New formulations and expanded vaccine production are encouraged.



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