OR WAIT null SECS
July 02, 2019
Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
July 01, 2019
More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.
June 25, 2019
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
June 24, 2019
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
June 20, 2019
FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.
The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.
June 19, 2019
CMA has issued a statement of objections provisionally finding that four pharmaceutical companies have broken competition law.
The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.