Quality Systems

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.

Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

The agency cites Apotex’s Bangalore facility with quality system failures.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.

QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? NeoStem has expanded it to include business and market issues, in "Development by Design." Could this be (or is it becoming) a new model for pharma?

The company announces that FDA has closed out a 2012 warning letter.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The industry reacts to the departure of Commissioner Margaret Hamburg.

FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.

The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.

Initiatives to speed drug development must pass Congress and special interest groups.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.