Quality/GMPs

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

The biopharma industry has had some successes but still needs to work on operational issues.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

The agency has recommended granting marketing authorization for Opdivo.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

The European Medicines Agency releases findings from marketing authorization application analysis.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

More reliable operations would accelerate product development and prevent drug shortages.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.

Drug makers back alternative to FDA labeling update rule.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.