Regulatory Authority Actions

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

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

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.

Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.

Demand for new therapies and vaccines spotlights production challenges.

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

FDA releases draft guidance on electronic submission of lot distribution reports.

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

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

FDA draft guidances seek to maintain accurate drug information in new media.

European Medicines Agency clarifies advanced-therapy medicinal products classification.

FDA releases guidance documents and rules on requirements for compounding human drug products.

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

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

EDQM details the agency?s accomplishments in 2013.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA issues guidance on the use of social media in regards to prescription drugs.

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.