Among the latest guidances pouring out from the U.S. FDA are ones addressing development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada.
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.
Another spate of U.S. FDA guidances for prescription drug manufacturers includes updates for carton labeling, product-specific advice and recommendations on mitigating potential drug shortages.
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies.
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information.
Ahead of U.S. President Joe Biden’s State of the Union address March 1 in which he gave a shoutout to his cancer moonshot initiative, the FDA released a trio of final guidances aimed at speeding the development of new cancer drugs. First launched in 2016 with the goal of doubling the rate of progress against cancer by making a decade worth of advances in five years, the moonshot was reignited last month with a new target following setbacks in cancer screenings and treatments during the COVID-19 pandemic. Now, Biden’s catch phrase is “ending cancer as we know it.”
Aiming to spur development of non-addictive pain therapies, as part of ongoing efforts to tackle the opioid crisis, the U.S. FDA released draft guidance Feb. 10 that outlines recommendations regarding development of opioid alternatives.
The U.S. FDA appears to be on a roll when it comes to rolling out new guidance pertaining to prescription drugs. In recent days, the agency has released draft guidances on antibody-drug conjugates and immunogenicity information in labeling, revised a draft guidance on assessing pressor effects of drugs and finalized a guidance on population pharmacokinetics.
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.
