The Food and Drug Administration (FDA) publishes a listing of fraudulent 2009 H1N1 Influenza products that have not been approved for diagnosis, prevention or treatment.
27/11/2009
THE US Food and Drug Administration (FDA) FDA charged Ranbaxy Laboratories’, Paonta Sahib facility, India has falsified data and test results in approved and pending drug applications.
13/03/2009
SOLOS Endoscopy has received FDA Level II Baseline Inspection and has received a NAI (No Action Indicated) marking after inspection of its premises.
11/03/2009
The US Food and Drug Administration (FDA) A has finalised a paper titled 'Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects', which includes an attachment specifically for those involved in medical device trials and their management.
05/11/2009
VISIONCARE Ophthalmic Technologies has announced the FDA Ophthalmic Devices Advisory Panel unanimously recommended the FDA approve, with conditions, the premarket application (PMA) for its implantable telescope for End-Stage age-related macular degeneration (AMD).
01/04/2009
The Food and Drug Administration (FDA) has issued safety information regarding Negative Pressure Wound Therapy (NPWT) systems. Healthcare professionals have been notified by the US authority regarding deaths and serious complications associated with the use of these systems.
24/11/2009
SYNTHEMED has announced that the US Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV Adhesion Barrier.
13/03/2009
SAGENT Pharmaceuticals has announced FDA approval of its Azithromycin for Injection therapy developed for treatment of bacterial infections.
31/03/2009
THE FDA has amended warning letters sent in March 2009 to nine companies asking them to stop manufacturing 14 unapproved narcotic drugs after realising the desperate need of one unapproved drug.
21/04/2009
ALCON has received FDA approval for its aspheric AcrySof IQ Toric intraocular lens (IOL).
03/03/2009
SPECTRASCIENCE has received FDA approval for its Luma Cervical Cancer Imaging System at its San Diego facility.
11/03/2009
AMERICAN Biotech Labs has announced it has been granted FDA approval to market it’s ASAP Wound Dressing Gel throughout the United States.
17/04/2009
THE FDA advisory committee have met to discuss the new drug application (NDA) for Bayer’s rivaroxaban.
25/03/2009
CSL Behring has been informed by the US Food and Drug Administration (FDA), that its RiaSTAP drug is entitled to seven years of ‘orphan-drug exclusivity.’
16/03/2009
ADVANCED Medical Optics has gained the approval of the FDA for distribution of an intraocular lens (IOL) for cataract patients.
27/01/2009
The US Food and Drug Administration (FDA) has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. This new vaccine extends the protection to six more types of the disease-causing bacteria than its predecessor Prevnar.
01/03/2010
VANDA Pharmaceuticals has compiled a report titled the “Common effect of antipsychotics on the biosynthesis and regulation of fatty acids and cholesterol supports a key role of lipid homeostasis in schizophrenia" for Schizophrenia Research, the official journal of the Schizophrenia International Research Society.
13/03/2009
DRUG delivery company pSivida says it will be webcasting a live presentation at the Cowen & Company Annual Health Care Conference.
17/03/2009
PRIMA Biomed has secured $12m in funding to advance the commercialisation of the CVac ovarian cancer vaccine treatment product.
17/03/2009
EXPRESSMD Solutions has announced it has received 510(k) market clearance from the FDA www.fda.gov for its remote patient health monitoring system.
17/04/2009