Regulatory Oversight and Compliance

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

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

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.

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

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.

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