What's new in October 2007

New for October

• 31 Oct 2007| New advice for medicines licence applicants using the European Decentralised Procedure

  Applicants are encouraged to let us know their plans as soon as possible in advance so we can agree submission and start dates.

• 31 Oct 2007| MDA/2007/083 - General ultrasound scanner: Nemio and Nemio XG systems manufactured by Toshiba Medical Systems Ltd

  Toshiba have identified a software error which could lead to an increased transducer tip temperature and an increased thermal index, along with incorrectly displayed MI (mechanical index) and TI (thermal index) values.

• 30 Oct 2007| Dietary supplements seized by US Food and Drug Administration (FDA)

  The US FDA (Food and Drug Administration) have seized Charantea Ampalaya Capsules and Charantea Ampalaya Tea dietary supplements marketed and distributed by FulLife Natural Optics.

• 29 Oct 2007| MHRA response to the termination of the BART Study on the use of aprotinin (Trasylol)

  Our response to the termination of a clinical trial (the BART Study) being conducted in North America due to a possible excess number of deaths in patients being treated with aprotinin compared to patients treated with the alternative drugs, epsilon aminocaproic acid or tranexamic acid.

• 29 Oct 2007| MDA/2007/082 - Counterfeit Durex condoms

  We have been informed that counterfeit Durex condoms have been placed on the UK market. There is no assurance that counterfeit condoms have been manufactured to appropriate standards.

• 26 Oct 2007| Press release: MHRA warns about counterfeit condoms found in Hackney

  We have been made aware that counterfeit condoms have been found in various retail outlets in Hackney, London.

• 25 Oct 2007| MDA/2007/081 - Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers - femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW

  DePuy CMW is recalling SmartSeal™ pressurisers used during cemented total hip joint replacement surgery because the outer peelable pouch seals may be creased and therefore may not be intact.

• 25 Oct 2007| Press release: MHRA invites researchers to access our data

  We are encouraging those in the research community to apply to use valuable data from the General Practice Research Database (GPRD) and the Yellow Card Scheme to help their studies to protect public health.

• 25 Oct 2007| Independent Scientific Advisory Committee for MHRA database research (ISAC) annual reports

  The first annual report by the Independent Scientific Advisory Committee for MHRA database research (ISAC) has been published.

• 24 Oct 2007| MDA/2007/080 - EMS ventilator circuits, product code W196-002 manufactured by Galemed Corporation

  A manufacturing problem has been identified where the valve in these breathing systems will not open, resulting in a blockage and potentially no oxygen being delivered to the patient.