Many manufacturers may wonder what mechanism is most appropriate to receive marketing approval from the Food and Drug Administration (FDA). Most Class I, II, or III devices are approved through either a premarket approval or a premarket notification (510(k)). Because approximately 80% of the devices currently marketed in the United States were approved through a 510(k), it is important for manufacturers to understand when and how to use this mechanism.

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Phil was having a horrible morning at the office. The recent inspection by the FDA had been stressful, but it was nothing compared to the letter that his administrative assistant had put in his office mailbox.

The letter now lay on his desk next to the FedEx envelope in which it had come, and the ominous title glared at him: “Warning Letter.”

He looked the letter over. It detailed all the violations that the inspector had found and told him the he needed to fix them and respond to the FDA within fifteen business days. He had been aware of the inspection’s findings and had been working to resolve the issues, but seeing them in the letter made them all more real.

He look out of the window of his corner office, saw the vast skyline spread out before him, and sighed. “What am I going to do about this?”

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John’s pharmaceutical company had grown tremendously over the past five years.

The results of phase three studies of the insulin pump that his company was developing had shown increased efficacy and safety compared with the competitors’ devices. He had also recently bought a plant in Canada to manufacture the insulin to support the device. However, he had a major problem.

The plant in Canada had never been used to manufacture insulin marketed in the United States. After reviewing the standard operating procedures and quality standards currently in place, he found that they had not been updated in a couple years.

Because he was first planning to market the device and the insulin in the United States, he needed to make certain that they complied with the FDA’s standards.

He consulted his company’s quality department on the matter, but found they were less familiar with the regulations associated with the manufacture of drugs, because until now the company had only dealt with devices. He wondered what would be the most cost-effective way to make certain they were following the FDA’s guidelines.

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The Food and Drug Administration (FDA) released a question and answer guidance on Abbreviated New Drug Application (ANDA) stability testing. This guidance will go into effect on June 20, 2014 and will cover all new ANDAs. However, it will not cover changes made after approval of an ANDA.

Affecting primarily generic manufacturers, the guidance is intended to make the FDA’s recommendations regarding stability testing data for an ANDA clearer. The recommendations should be followed regardless of the status of a patent.

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With today’s rising costs in healthcare, there has been increasing pressure to market drugs that are more cost effective. One such solution is to prescribe generic drugs. According to the Food and Drug Administration (FDA), approximately 80% of the drugs prescribed today are generic. These drugs can be two‑thirds cheaper than their brand‑name counterparts. However, the process by which generic drugs are approved differs from that for brand-name drugs.

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