The US Food and Drug Administration (FDA) has ordered makers of testosterone therapies to change their labelling and conduct clinical trials to investigate heart attack and stroke risk.
A US CMO industry group has backed plans to exempt privately paid user fees from Government spending cuts enforced if US politicians fail to agree a budget.
Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.
The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and...
A Fresenius Kabi plant in New York has been upgraded, and up to five new products could receive FDA approval, almost three years after receiving a warning letter.
The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.
Industry won’t see much of an initial impact from the US FDA’s newly formed Office of Pharmaceutical Quality, though in a couple of years the agency will have more benchmarks and new technology to find and single out the worst manufacturers.
Shire says its $5.2bn (€4.4bn) acquisition of NPS Pharmaceuticals is a calculated risk, coming just days before the US FDA decides whther to approve the hormone replacement therapy Natpara.
Almost two years since it was first rejected, Impax Pharmaceuticals said late last week that the US FDA has approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease.
Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.
The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.
The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.
Drugmakers including China in multi-regional trials would need to submit dossiers filed elsewhere for CFDA review, open up non-Chinese sites to inspections and conduct local studies under draft guidelines proposed by Beijing regulators.
Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the US Food and Drug Administration (FDA) decides whether to approve the new drug.
As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.
US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.
A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.
Jordanian drugmaker Hikma says it has received a US FDA (Food and Drug Administration) Warning Letter over environmental monitoring at its plant in Portugal.
Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.
Hospira has received a US FDA Warning Letter at an Australian injectables facility months after workers asked the firm not turn the site into “the new Rocky Mount.”
Indian generic manufacturer Marck Biosciences has received a warning letter from the US FDA for failing to pay its annual facility fees for the past two years, which for foreign fixed-dose formulation facilities in 2014 was $235,152.
Hampered by manufacturing issues, Impax Laboratories has decided to settle a lawsuit over allegations related to the issues in order “to eliminate the uncertainty, distraction, burden and expense of further litigation,” the company said in a SEC filing.
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
A former researcher of the now dissolved CRO Cetero Research told us the warning letter he received from US FDA was “contrived” because of the way the inspection was conducted.
A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.
Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.
Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.
Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.
The US Food and Drug Administration (FDA) is inviting public comment on plans to allow drug companies to reserve proprietary names for medicines as early as the end of Phase II trials.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
