Quality/GMPs

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

New publications from BPSA and PDA highlight best practices for particulate control, quality agreements, and implementation strategies.

The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.

USP releases compendium of quality standards for compounded medicines.

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.

The European Medicines Agency responds to the European Ombudsman's letter regarding redacted documents.

FDA releases guidance specifying its preferred unique facility identifier system.

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.

The authors take a look at some of the recent developments in the German pharmaceutical market.

The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Defining critical parameters and processing large quantities of data can be a challenge.

The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

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

Two lots of empty intravenous fluid bags were voluntarily recalled because of the presence of particulates.

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.

Pfizer's addition of a new vaccine suite and multiproduct bioprocess suite to its Ireland facility win the company the title of 2014 Facility of the Year.

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.

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

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