Industry News

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.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

The author explores various biocontainers-both old and new-in the single-use space.

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.

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.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

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

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

The agency releases five draft guidance documents related to drug compounding and repackaging.

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

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

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

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

The recent mergers, partnerships, and incentive-laden deals in pharma may keep the industry from continuing to experience diminishing returns, according to IMS’ Michael Kleinrock.

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

President Obama unveils his “Precision Medicine Initiative”.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

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

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.