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September 02, 2018
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
September 01, 2018
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
August 30, 2018
The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
August 29, 2018
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
August 28, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.
Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.
August 27, 2018
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.