Regulatory Watch

Operational changes at FDA and CDER aim to improve global market monitoring.

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.

Demand for new therapies and vaccines spotlights production challenges.

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

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.

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

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

New formulations and expanded vaccine production are encouraged.

New identifiers and tracking requirements aim to block illegitimate products.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

Manufacturers are taking measures to comply with new package safety rules.

Accelerated testing and production create challenges in documenting product quality.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Manufacturing standards are considered key to preventing drug recalls and shortages.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

Compounding, tracking legislation moves forward

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.