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March 04, 2019
FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
March 02, 2019
Bio/pharma companies facing new challenges in light of the increasing HPAPI market may benefit from outsourcing.
The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
March 01, 2019
Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.
February 25, 2019
A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.