FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.
Some members of a Food and Drug Administration advisory panel had questions and others didn’t about HRA Pharma’s actual user study data but all voted to recommend the agency approve the firm’s proposal for the first OTC switch of an oral contraceptive in the US.
FDA officials again made clear their concerns about “improbable dosing” data in HRA’s supplement new drug application for its 0.075-mg...
What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.
Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.
“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.
While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.
“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.
Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.
Texas Democrat Lizzie Fletcher didn’t pose questions for witnesses at House Health Subcommittee hearing but used her floor time to question whether Congress will keep federal agencies afloat. “I have real concerns that even if we reauthorize these programs, we won't have the funding or the staff to
