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FDA publishes a guidance listing items to consider when developing and designing interoperable medical devices.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on Providing Regulatory Submissions in Electronic Format Content of...[ Price : $8.95]
Insmed plans to seek accelerated approval of its inhaled therapy Alis (amikacin) based on data from the CONVERT study in adult pat...[ Price : $8.95]
Federal Register notice: FDA creates a public docket to collect comments related to pediatric post-marketing pharmacovigilance and...[ Price : $8.95]
FDA says its updated analysis supports continuing to make ketoconazole 200 mg tablets available on the market for its limited indi...[ Price : $8.95]
FDA denies a United Therapeutics petition asking it to establish specific requirements for approving an ANDA for generic Tyvaso, w...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes MB Industria Cirurgica, QLRAD Netherlands, Steiner Biotechnology an...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion Warns Cipher about a professional detail aid that omits references to risk information...