On April 23, 2014, the Food and Drug Administration (FDA) proposed a new voluntary program to accelerate approval of devices that show promise in treating debilitating or life-threatening conditions for which a need has not been met. Called an Expedited Access Premarketing Approval (PMA) or EAP, this program would allow sponsors to market devices that treat these conditions more quickly.
FDA has begun cracking down on drug makers that import their products into the US. Many of these have involved generic drugs that are made in India. In fact, in April of this year, FDA banned imports of many generic drugs that are associated with the drugmaker Apotex.
That company has a large manufacturing base in India, most likely to keep production costs low. However, Apotex is just one firm in a long list with facilities in India that have been sanctioned in the last year. Others include Ranbaxy, Sun Pharmaceutical, and Wockhartdt.
Late in 2013, FDA gave its approval to a long-acting type of the opiate hydrocodone. It is sold as Zohydro ER by the company Zogenix. It has been approved for pain management for patients who have severe pain issues due to illness or disease.