Medical technology industry association MedTech Europe is seeking urgent talks with European Union (EU) institutions and affected stakeholders to push back the May 2020 deadline for the Medical Devices Regulation (MDR), following slow progress in building the required infrastructure for implementation.
Medical technology industry association MedTech Europe is seeking urgent talks with European Union (EU) institutions and affected stakeholders to push back the May 2020 deadline for the Medical Devices Regulation (MDR), following slow progress in building the required infrastructure for implementation.
“The industry is calling urgently on the European Commission, the European Parliament and all EU Member States to provide solutions...
Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.
Updating wastewater treatment facilities in Germany will cost almost three times more than the German Association of Local Public Utilities (VKU) has predicted, according to a Pharma Deutschland analysis.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
FDA admonishes five marketers for straying from approved sunscreen dosage forms in recent warning letters. Violative delivery formats render products unapproved drugs and misbranded.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
