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The FDA is publishing a draft guidance this week to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC “Drug Facts” format.
A December 2004 draft guidance released by the FDA states that drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms—including crystalline and amorphous forms, as well as solvate and hydrate forms.
The FDA next month will hold a public meeting to review the status of the Study Data Tabul-ation Model (SDTM) for clinical trial data submissions and to discuss the agency’s experience with and plans for the proposed standard format, which was developed by the Clinical Data Interchange Standards Consortium (CDISC).
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an update to how adverse incidents are reported to the agency, including the use of the new Safety Alert Broadcast System (SABS).
Prompted by a request from Wyeth, the FDA has reopened the public comment period for two International Conference on Harmonisation (ICH) draft guidances that assess possible cardiac risks associated with new drugs.
The FDA issued a proposed rule Jan. 5 to amend the tentative final monograph (TFM) for OTC drugs that are used to relieve symptoms associated with overindulgence of food and drink to include new indications for products containing bismuth subsalicylate.
The FDA has released a draft compliance guidance to help firms understand new OTC product labeling requirements as well as prepare new labeling within prescribed implementation compliance dates.
Drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms — including crystalline and amorphous forms, as well as solvate and hydrate forms, according to a draft guidance released by the FDA.
The FDA issued three Class II special controls guidances last week to address the reclassification of three device types — assisted reproduction laser systems, external penile rigidity devices and certain embolization devices.