US FDA’s 2019 Drugs Trials Snapshots show female participation in clinical trials of the drugs approved during the past year increased, although ethnic diversity remains an issue.
Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.
US FDA approves Fetroja, an antibiotic developed by Shionogi, for the treatment of complicated urinary tract infections, as part of the effort to fight AMR.
FDA urges manufacturers to ‘sell quality’ to fight drug shortages, releasing a report on the potential introduction of a rating system to reward transparency and investments in quality management.
Celgene’s Inrebic becomes the first treatment for myelofibrosis to be approved by the US FDA since 2011 after having received a priority review and orphan drug designation.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.
Two Chinese and one Korean over-the-counter (OTC) drugmakers have received US FDA warnings for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.
CTTI has completed more than 25 projects on issues affecting clinical trials over the past decade, since which time the industry has changed greatly, says executive director.
Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
Paragon Bioservices plans to open a new 150,000 square-foot facility to help fulfill a growing demand for the company’s gene therapy manufacturing services, says CEO.
The US Government shutdown only lasted one working day but the US FDA could take weeks to make up the lost time according to the Alliance for a Stronger FDA.
The Tjoa Group has launched Meditraq to help firms across the pharmaceutical supply chain meet data requirements, one year out from the EU serialization deadline.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
Parexel has enhanced its clinical data service offering with the addition of new features to further support data collection and analysis as well as adaptive trial design.
The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.
Regulatory changes and promising starts ups are fueling demand for outsourced services in China – and as venture capital flows into the country, the pace of innovation is expected to accelerate, says STA Pharmaceutical.
The US FDA says it observed quality documents in the teeth of a staff room shredder and lenient computer access at Glenmark’s Baddi facility in India, which was issued a Form 483 last week.
The US Food and Drug Administration (FDA) has released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases.
Cannabinoid firm GW Pharmaceuticals says it is “inspection ready” as it prepares for potential US approval of its epilepsy candidate Epidiolex (cannabidiol or CBD).
