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.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
US FDA approves Noven’s schizophrenia treatment administered through a once-daily transdermal delivery system, able to release the antipsychotic drug for 24 hours.
The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.
US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
Aetion today announced that former FDA Commissioner Scott Gottlieb has joined its board of directors to help to advance the use of RWE in drug development and commercialization.
The US FDA issues a Form 483 to Shilpa Medicare, after an investigation noted five observations that require action, including an unreliable power supply.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
Rinvoq from AbbVie to be available in the US in late August 2019, after receiving FDA approval for the treatment of adults with active rheumatoid arthritis.
After 2018 saw numerous sartan drugs recalled for possible carcinogenic impurities, in 2019, the industry kept an eye on the regulatory issues that followed and the breakthroughs that have mitigated some of the risks.
Seres Therapeutics draws distinction between its quality practices and those of the fecal microbiota for transplantation (FMT) operations that triggered FDA alert.
Daiichi Sankyo’s Turalio becomes the first FDA-approved TGCT treatment, after receiving breakthrough therapy, priority review and orphan drug designation.
Aptar’s needle-free, emergency powder formulation treatment for patients with diabetes and severe hypoglycemia is the company’s first combination drug delivery device with active packaging.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Regulatory actions by the FDA have enabled rare disease drug development to become a compelling space with orphan drug designations and approvals trending upward, says life sciences industry attorney.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.
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.
In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...
