Regulatory Oversight and Compliance

The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.

FDA found no observations during recent inspection of Regis Technologies manufacturing site.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

Sandoz won FDA approval for its biosimilar version of Enbrel.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.

FDA issued a warning letter to College Pharmacy for multiple violations.

The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.

FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The three-year report emphasizes the roll of collaboration in drug safety.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.

Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.