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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
How a monograph, general notices, and general chapters relate to good manufacturing practices.
Industry should improve the standards for detecting drug impurities.
With many on-site visits on hold, FDA seeks alternatives
January 27, 2021
Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
January 26, 2021
Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
January 25, 2021
The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.
January 19, 2021
Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.
January 14, 2021
As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.
January 11, 2021
The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.
The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.
January 07, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.
EMA has chosen Panalgo's Instant Health Data (IHD) platform to enable rapid analyses of real-world data.