Regulatory Beat

Manufacturers challenge details in new policies designed to promote access to important therapies.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

FDA and industry support global framework and collaborations to secure the supply chain.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

More reliable operations would accelerate product development and prevent drug shortages.

Scientists and industry experts seek effective preventive therapies to combat global disease.

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

The industry reacts to the departure of Commissioner Margaret Hamburg.

Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.

EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

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.

Demand for new therapies and vaccines spotlights production challenges.

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.

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

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.