Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches, the stance of the FDA’s oncology division on confirming benefit after an accelerated approval, and why formal meetings between the agency and sponsors cannot be recorded.

Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents, DTC promotion practices as part of acquisition due diligence, and how Intarcia’s advisory committee decision appeal could play out.

Pink Sheet reporters and editors discuss new off-label use communications guidance, how price negotiations could impact prescribing, and Monica Bertagnolli’s nomination for NIH director advancing.

Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.

Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.

We used the US holiday weekend to upgrade our platform, so there are lots of stories to catch you up on, from Korean regulatory legislation to German exclusivity litigation.