CDER Outlines its Drug Safety Priorities During the Pandemic
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks,…
Alembic Pharmaceuticals Draws Form 483 Over Five Quality Observations
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Source:…
Vaccine Developers Face Challenges in Scaling Up Manufacturing
A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. Source: Drug GMP Report
FDA Warns Florida Manufacturer Over Quality, Validation Concerns
Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses,…
AcelRx Pharmaceuticals Draws Warning Letter for Misleading Claims
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to AcelRx Pharmaceuticals over false and misleading claims it made for its oral opioid Dsuvia (sufentanil). Source: Drug…
Fresenius Kabi’s Cancer Drug Subsidiary Pleads Guilty to Destroying Records
Fresenius Kabi Oncology (FKO) has agreed to plead guilty to hiding and destroying records prior to a 2013 FDA inspection and will hand over $50 million in fines and forfeiture,…
New Initial Question Coming Soon to FDA Adverse Event Reporting System
In just over four months, drug manufacturers will experience a change in the FDA’s online adverse event report system to help the agency figure out what stage the product the…
European Commission Signs New Supply Deals With Pfizer and Moderna
The EU has struck new supply agreements with Moderna and Pfizer, boosting its total COVID-19 vaccine arsenal to up to 2.6 billion doses, enough to inoculate the bloc’s 446 million…
Woodcock Rebuffs Proposed ‘Firewall’ Between FDA Staff Following Aducanumab Dispute
Acting FDA Commissioner Janet Woodcock rejected a proposal to put up a “firewall” between FDA staff involved in pre-submission interactions and staff working on post-submission drug and biologic reviews and…
GSK and Vir Biotechnology Expand Monoclonal Antibody Partnership
GlaxoSmithKline (GSK) and Vir Biotechnology have teamed up to develop monoclonal antibodies for respiratory viruses, building off an existing agreement struck last year to develop COVID-19 therapies. Source: Drug Industry…