Quality Systems

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling batches of hyoscyamine sulfate (0.125mg).

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.

A customer complaint revealed microbial contamination issues affecting lots with expiration dates in late 2018 and early 2019.

Mumbai, the location for its new Indian subsidiary, will also be the site for the company's Uniquity Global Conference on October 6, 2016.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

The Indian facility was cited for a range of quality and data integrity violations.

The agency published a guideline for the implementation of ICH Q3D.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.

Industry experts discuss recent trends in modular manufacturing.

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Visual inspection of parenteral vials is the first step in a root cause investigation.

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

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

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The CordenPharma Chenôve, France manufacturing facility completed an FDA Inspection with no 483s reported.

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