Quality/GMPs

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Operational changes at FDA and CDER aim to improve global market monitoring.

The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

Performing degradation studies is the best strategy to evaluate toxicity risk.

FDA will delay its decision regarding the new drug application for panobinostat.

USP and ChP jointly host two-day meeting to strengthen cooperation.

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

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FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.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