Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
The US House of Representatives has passed a bill by voice vote that would for the first time create a system to track and trace drugs through the supply chain.
Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from...
One day after Purdue Pharma’s blockbuster opioid OxyContin lost its first patent, the US FDA has amended the drug’s label and now requires generic drugmakers to adopt similar abuse-deterrent formulations.
The US FDA is giving generic drug facilities one month to self-identify for FY 2014 so that the agency can calculate how much to charge the companies in user fees for application reviews and inspections.
President Obama’s FY 2014 budget request of $4.7B for the US FDA would increase the agency’s ability to inspect foreign drug manufacturers and clinical trial sites.
The US FDA has reprimanded and halted all imports from Japanese API manufacturer Asada Milling Co. after finding its manufacturing equipment “corroded, rusted, chipped of paint, and coated with an unidentified white powder,” the agency said in its warning...
Pfizer, Merck, Eli Lilly and a number of other large pharmaceutical companies are calling on the FDA to supplement draft guidance on enrichment strategies for clinical trials with more examples from different therapeutic areas.
The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter published this week.
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create...
The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its proposed rule from 2009.
Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.
The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg said in a letter to Rep. Fred Upton (R-Mich.)...
Positron emission tomography (PET) drug manufacturers have three years to gain NDA or ANDA approval or they must remove their products from the market according to the US FDA.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
The US FDA has issued a warning about Hospira’s Carpuject prefilled cartridges after batches were found containing more than twice the amount of recommended dosage.
The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.
