The DEA's mismanagement of the controlled substance API quota system and its poor relationship with the FDA have exacerbated drug shortages according to the US GAO.
Despite slamming the US FDA for tentatively approving two Ranbaxy ANDAs (abbreviated new drug applications) for the first Nexium and Valcyte generics, US District Judge Beryl Howell said last week the agency can revoke the approvals because of manufacturing...
More drugs for tropical diseases have been donated since the London declaration of 2012, but getting them to the remote communities is still a challenge according to a consortium led by the Liverpool School of Tropical Medicine (LSTM).
Chinese cancer drug developer BeiGene will create production cell lines using a platform developed by Sigma Aldrich's custom manufacturing services business.
Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.
Patients who mix Chantix with alcohol can become aggressive or suffer memory loss says the US FDA, which has ordered Pfizer to update the smoking cessation drug’s side-effects label.
J&J unit McNeil-PPC has admitted breaking US law by selling contaminated liquid medications, including Infants’ Tylenol and Children’s Motrin, deemed adulterated under the federal Food, Drug and Cosmetic Act (FDCA).
The Danish and Austrian authorities have warned against toxic food supplements ahead of an EU-wide safety logo set to crack down on illegal retailers posing as online pharmacies.
