Generics
The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.
New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.
Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.
The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.
The introductory meeting did not suggest changes to the expected schedule and operations for renewing the generic drug user fee, said AAM’s Giuseppe Randazzo.
The latest incentive for firms to move manufacturing to the US is an FDA pilot program that will prioritize the review of US-manufactured and tested ANDA products.
An FDA approval of Evita Solutions' generic mifepristone 200mg tablets has reignited debate about the abortion pill, which Health and Human Services Secretary Robert F. Kennedy Jr. has indicated will be subject to a safety review.
The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.
Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.
In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.
The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
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.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.
Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.