Regulatory Authority Actions

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

GAO calls for more oversight of institutional review boards in clinical trials.

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

The BsUFA facilitates the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions.