UNASSIGNED: An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical device guidelines has been basically stable, then rapidly rose.
UNASSIGNED: The rise of the COVID-19 pandemic and digital health technologies explains 50% of the upward momentum in guidelines since the mid-2010s. Concomitantly, medical device and medicinal guidelines became moderately correlated. This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of \'innovation saltus\' - i.e. discrete periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science; namely, examination of guidelines (as proxy measures of regulations) and their influence on innovation.

Currently, sixty-five original sprinkle drug products are available in various dosage forms including tablets, powders, granules, immediate-release capsules, extended-release capsules, delayed-release capsules, and multiparticulate drug delivery systems. By sprinkling on soft food vehicles, these products provide dosing flexibility and convenience of administration, which potentially improve the compliance of patients with dysphagia. Due to these advantages, the growth of sprinkle products picked up since the 1990s, and several regulatory issues regarding this dosage form have been raised and documented. In this article, the types of sprinkle formulations were discussed by dividing them into seven categories, and the commercial products were summarized in terms of the drug substance, pharmaceutical excipients, storage conditions and administration methods. In addition, several US Food and Drug Administration guidelines related to the regulatory issues of sprinkle formulations were reviewed, which led to the conclusion that the future development of this promising dosage form demands integrated guidance for industry rather than scattered information in various documents.

BACKGROUND: In 2012, the US Food and Drug Administration (FDA) issued the draft guidance \"Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.\" The selective data collection approach proposed in this guidance leads to reductions in costs and work time and may improve the quality of the database for clinical trials. The current study evaluated the applicability of selective data collection for oncology drugs.
METHODS: The labeling information of oncology drugs obtained supplemental approvals from the FDA between 2005 and 2014 were used. The frequency of adverse reactions observed in clinical trials between the first approval and supplemental approvals of a specific drug were compared. Paired studies were categorized into the following 4 groups: A, same tumor type and same usage; B, same tumor type and different usage; C, different tumor type and same usage; D, different tumor type and different usage.
RESULTS: A total of 46 study pairs for additional drug indications were investigated. In group A, 6 of the 7 pairs showed a high correlation coefficient ( r = 0.988, 0.953, 0.947, 0.935, 0.853, and 0.846).
CONCLUSIONS: Selective data collection should be adopted in cases in which the additional indication of a drug is for the same tumor type and usage as the first or previous indication.