Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
The evidence is clear: Patients don't properly use drug delivery devices like inhalers or epinephrine autoinjectors--such as Mylan's EpiPen.
A host of drugmakers will not have to pull from the market, at least for now, generic drugs that German regulators say are suspect. The companies have bought some time with appeals of a decision by regulators to nix sales of dozens of medications because of flaws in clinical trials handled by an Indian contractor.
The veterinary nonsteroidal anti-inflammatory drug diclofenac was banned in several South Asian countries after the product was linked to mass deaths of vultures there. But diclofenac was recently approved in Spain and Italy--sparking an outcry from an international team of veterinarians, conservationists, and biologists, who argue that the drug will put Europe's vultures at risk of extinction.
A new study shows that patients who are prescribed opioids continue to use them over a long period of time, indicating potential abuse and adding fuel to the fire as lawmakers and industry groups continue to crack down on companies producing the drugs.
The FDA closed another chapter in regulating errant compounders when the co-owner of Main Street Family Pharmacy, a Tennessee-based compounding pharmacy, pleaded guilty in federal court to a misdemeanor criminal violation related to a contaminated steroid that caused 26 people to become ill.
Bayer and Johnson & Johnson are fighting a consolidation of lawsuits over their top-selling anticoagulant Xarelto, months after patients filed suit in the U.S. accusing the companies of downplaying the drug's risks.
A new plan has been filed to establish a fund of at least $135 million in compensation for victims and families affected by a 2012 fungal meningitis outbreak that killed 64 people, sickened hundreds and led to Congress granting the FDA new powers to regulate compounding pharmacies.
Novartis' Fluad influenza vaccine has been declared safe by another regulator, this time the European Medicines Agency, after being called into question following the deaths of patients in Italy who had been given the jab.
Italy's drug regulator has a growing investigation on its hands, and Novartis is in the middle of it. The number of people who have died in the country after receiving one of the Swiss pharma giant's flu vaccines has risen by 10 just days after Italy issued a partial ban on the product.