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The results of the 2014 Scope of Practice & Compensation Report for the Regulatory Profession,
consistent with past surveys, show regulatory careers continue to offer
good pay, growth opportunities and challenging and diverse work.
The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency.
The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited review process for any subsequent drug product.
Senate legislators have released a new iteration of the Sunscreen Innovation Act, a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs.
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Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might soon be focused there. View More
In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. View More
The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals. View More
9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape
It can be profoundly difficult to monitor—let alone make sense of—the regulatory affairs environment. Thanks to constantly changing laws, regulations, policies, legal developments, technologies and sou View More