Regulatory Oversight

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.

Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.

Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

The agency cited the company’s India facility for batch failures and data integrity problems.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

EMA has developed a framework and action plan to foster relationships with the academic community.

Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.

Industry fears limited benefits as FDA readies voluntary data tracking program.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.

Continuous manufacturing will not work for all pharmaceuticals, but the right infrastructure, senior management support, and planning from the earliest stages of drug development could eventually allow up to 80-90% of small-molecule APIs to be made continuously, says Paul Sharratt, head of process science and modeling at Singapore’s Institute of Chemical and Engineering Sciences.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.