Quality Systems

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

The report examines the increased number of companies cited by regulators for data integrity issues.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.

The inspection confirmed that the facility was compliant with GMP guidelines.

Policy makers debate strategies for promoting access to less costly medicines.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

Data integrity is a widespread, global problem that must be addressed.