Quality Systems

The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

Generic drug manufacturing is no longer the only driver for growth in India's pharmaceutical market as more companies start investing in R&D.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

CDMO Vetter announced the addition of a new flexible serialization service, introduced in response to stricter packaging regulations calling for drugs to be serialized as a means to fight counterfeits.

The spate of drug scandals may alter the relationship between manufacturers and research institutions, and reshape Japan’s clinical research industry.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

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

Dual sourcing is one of many possible solutions to securing the supply chain.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

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

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses the requirements for good distribution practices.

Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

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

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

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.

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

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

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.

Analytical procedures and method validation should be developed with a structured and rigorous approach.

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.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.