Regulatory Oversight and Compliance

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Resolving the problem will require more communication between the industry and regulatory bodies.

The authors explore and define common industry approaches and practices when applying GMPs in early development.

The European Union takes the lead in a global pilot project on the marketing approval of generic medicines, highlighting the challenges of achieving consensus among different nations.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.

The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

Demand for new therapies and vaccines spotlights production challenges.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

Brazil's pharmaceutical industry is optimistic, but is the pharmaceutical market growing steadily or showing signs of instability?

Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.

The campaign supports pharmaceutical growth in India and serves to highlight the value proposition that Indian pharmaceuticals present.

FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

FDA demands accurate manufacturing and test information to ensure product quality.

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

FDA found violations of cGMP at finished-drug manufacturer in India.

The European system for assessing drugs will be used as a model internationally.

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.