Information from the CHPA-commissioned study could help improve policymakers’ understanding of the costs of making OTCs less available as well as the benefits of more Rx-to-OTC switches.
The Consumer Healthcare Products Association hopes $102 billion in annual health care savings will draw attention to its arguments for expanding access to OTC drugs.
The trade group Jan. 31 published information from research it commissioned that looked at, among other things, how U.S. consumers’...
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Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.
Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.
Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.
New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.
The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.
