Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

DBV Technologies (DBVT) announced that in a written responses only to the company’s Type D IND meeting request, the FDA agreed with the ...

It is designed as a self-administered rapid response therapy for patients ... the outcomes of future interactions with the FDA, including the potential Type A meeting; the outcome of the potential ...

We are very happy to have been granted a meeting with the FDA to review the positive OnTarget ... effective than placebo in providing sustained response in breast cancer patients." ...

"FDA has rarely (if ever) not agreed with WHO strains," Bright wrote on X. "This is not the place to burn midnight oil fretting about a meeting." ...

Eva Temkin, a lawyer at Arnold & Porter who advises clients on medical device applications, said the FDA had canceled some meetings with companies or reverted to providing written responses only.

We are very happy to have been granted a meeting ... sustained response in breast cancer patients." Members of Napo's SAB are expected to join Jaguar representatives at the FDA meeting in the ...

She said the FDA had already canceled some meetings with companies or reverted to providing written responses only. A lawyer specializing in FDA regulation, who spoke on condition of anonymity ...