FDA

iSpeak Blog
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
Features
Eli Lilly and Company’s continuous manufacturing (CM) kits have proven to be an important manufacturing platform for the company’s oral solid dosage products (OSD). “CM is very important to Lilly as one of our proven manufacturing platforms for...
Features
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs...
iSpeak Blog
Gilead Science’s 28 August purchase of Kite Pharma, Inc., one of the companies developing CAR T-cells, a therapy that harnesses the body’s own immune system to recognize and attack malignant cells, paid off in spades last week. On Wednesday, 18 October,...
News & Press Releases
15 October 2014
ISPE released its Drug Shortages Prevention Plan yesterday during 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Medicines and Healthcare Products...