US FDA has issued the final guidance for Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers1 for Human Use.
ISPE announced the release of their latest Guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts. This publication provides detailed practical guidance to support data integrity within a regulated organization.
Countries around the world today agreed to the Declaration of Astana, vowing to strengthen their primary health care systems as an essential step toward achieving universal health coverage.
The Declaration of Astana reaffirms the historic 1978 Declaration of Alma-Ata, the first time world leaders committed to primary health care.
U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status.
Novartis announced that it has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Under the terms of the agreement, Novartis would acquire all outstanding shares of Endocyte common stock for USD 24 per share. This offer values Endocyte's equity at USD 2.1 billion.
Fruits and vegetables are a key part of a healthy diet. But because of the way produce is grown, handled and consumed – often raw – it can become contaminated with foodborne pathogens that may make consumers sick. Farmers understand the importance of food safety when they grow their crops. So did Congress when it passed the FDA Food Safety Modernization Act (FSMA). This law, for the first time, charged the FDA with establishing science-based standards for the safe production and harvesting of produce.
SCHOTT AG, a global pioneer in manufacturing pharmaceutical glass and packaging, has announced the launch of a new glass tank in its Indian manufacturing plant at Jambusar, Gujarat. The German technology group is further growing its production capacity through this new tank facility with a total investment of more than 20 million euros. The invest comes at a time when the company is celebrating 20 years of operations in India.
Amgen and Oxford Nanopore Technologies Ltd. announced Amgen's equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.
EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.