20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.
20-Aug-2014 - Eisai has accused the US FDA of unlawfully shortening market exclusivity periods for Belviq and Fycompa by starting the countdown one year before either was scheduled by the DEA.
20-Aug-2014 - Nearly a month after India pushed back its deadline indefinitely for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade (DGFT) has set a new deadline of April 2015.
20-Aug-2014 - 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.
19-Aug-2014 - Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.
18-Aug-2014 - All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.
14-Aug-2014 - Roche has tapped into its antibiotic stockpile to aid Red Cross relief efforts in Yunnan, China which was struck by a major earthquake earlier this month.
13-Aug-2014 - The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.
13-Aug-2014 - Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
12-Aug-2014 - Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
12-Aug-2014 - GSK has stopped using an ethanol storage tank at a US R&D facility and agreed to pay a fine to settle US Environmental Protection Agency (EPA) allegations that it broke waste management laws.
11-Aug-2014 - For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).
07-Aug-2014 - In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
06-Aug-2014 - The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell in-PharmaTechnologist.com.
06-Aug-2014 - A week after receiving an FDA Form 483 for its Taiwan site , Impax Laboratories received another Form 483 for its Hayward, California site.
05-Aug-2014 - The European Medicines Agency (EMA) has issued a concept paper on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of the use of animals in tests.
31-Jul-2014 - 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.
31-Jul-2014 - The UK All-Party Pharmacy Group (APPG) has warned Britain is suffering from a shortage of branded and generic drugs.
30-Jul-2014 - 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.
28-Jul-2014 - The latest changes at Bayer, biopharma, and the winner of Professional Woman of the Year in this week's column.
28-Jul-2014 - 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.
24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.
24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.
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