USFDA

Karkhadi (Gujarat) based plant of Sun Pharmaceuticals imposed ban by USFDA. This ban is applied on import of all drug products from this plant. This detention was carried out without physical examination of drugs because company failed to met good manufacturing practices rules, as per FDA website on Wednesday.

During  their last investigation in April 2013 at Canton Laboratories- Vadodara,  U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.

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U.S. Food and Drug Administration allowed marketing of the first device, Cefaly-manufactured by STX-Med in Belgium, as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

A new "cluster" have set up on medicinal safety topics by join efforts of U.S. Food and Drug Administration and the European Medicines Agency (EMA). Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

The USFDA approved Chelsea Therapeutics's product Northera capsules (droxidopa), orphan-product, for the treatment of neurogenic orthostatic hypotension (NOH) which is rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy,

The US health regulator has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices (CGMP).

The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.

The American Society of Anesthesiologists (ASA) has asked the US Food and Drug Administration (FDA), for the sake of patient safety, to work with foreign governments to allow for the importation of sodium thiopental (Pentothal, Hospira) because domestic production of the controversial agent ceased in 2009.

The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.