FDA Offers Advice on Control of Nitrosamines in Drugs
The FDA released a straight-to-final guidance on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Source: Drug GMP Report
FDA Outlines Prescription Drug Labeling for Geriatric Patients
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance…
Warning Letter Roundup: FDA Raps Five Firms for Testing, Other Violations
Five drugmakers drew warnings from the FDA for serious quality failures, including “superpotent” products, inadequate stability data and a lack of validation testing. Source: Drug GMP Report
Be Careful With FDA’s New Compliant-Manufacturing Resumption Guidance
Jack Garvey, founder and CEO of Compliance Architects, a firm specializing in GMP, quality and compliance services, calls for caution in applying the FDA’s new compliant-manufacturing resumption guidance. Source: Drug…
FDA Provides Clarifications on Evaluations for Intended Use
In a proposed rule, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for…
FDA Issues Temporary Guidance on Resuming Normal Drug Manufacturing
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that…
EU Signs COVID-19 Vaccine Supply Deal With Sanofi/GSK
In the European Union’s (EU) latest move to secure supplies of a COVID-19 vaccine, the European Commission (EC) has signed a contract with Sanofi and GlaxoSmithKline (GSK) for 300 million…
EMA Expert Group Recommends Dexamethasone for COVID-19
The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy. Source: Devices & Diagnostics…
Lawmakers Lash Out at White House Over Hahn Testimony on COVID-19
Leaders of the House Energy and Commerce committee on Friday lashed out at the Trump administration for allegedly blocking Commissioner Stephen Hahn from testifying about the agency’s COVID-19 response. Source:…
State Treasurers Accuse Gilead of Seeking ‘Unreasonable Profits’ From Remdesivir
In a letter to Gilead Sciences, almost a dozen state treasurers accused the company of seeking “unreasonable profits” from its antiviral COVID-19 treatment remdesivir, demanding that it lower the price.…
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