Regulatory Authority Actions

FDA clarifies stability data recommendations for abbreviated new drug applications.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

The European Medicines Agency's Annual Report highlights the agency's drug approvals, projects, and initiatives for 2013.

EMA notifies EU healthcare professionals of the falsified cancer drug Herceptin.

New identifiers and tracking requirements aim to block illegitimate products.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

HHS plan makes progress in ensuring availability of safe vaccines.

Agencies extend successful pilot program to further harmonization of QbD topics.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Accelerated testing and production create challenges in documenting product quality.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

USP evaluates quality attributes for synthetic peptides.

Manufacturers are taking measures to comply with new package safety rules.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA and EMA set up regular meetings to harmonize drug safety actions.

Thirteen companies are accepted for participation in the supply chain program.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.