September 28th 2023
The agency will be reorganizing field force and compliance functions.
August 1st 2023
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
July 1st 2023
Problems continue despite actions by regulators to better prevent and address drug shortages.
June 1st 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
May 1st 2023
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
FDA Faces Controversy Over Quality Metrics and Biosimilars
Manufacturers challenge details in new policies designed to promote access to important therapies.
Manufacturers Face Key Policy and Regulatory Challenges
Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.
Campaign Against Fake Drugs Gains Momentum
FDA and industry support global framework and collaborations to secure the supply chain.
Unravelling the Complexity of EU’s ATMP Regulatory Framework
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Quality Systems Key to Lifecycle Drug Management
Regulators and industry seek to streamline and harmonize oversight of postapproval changes.
FDA Revises Field Inspections to Reflect Global Market and Quality Initiatives
Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.
Modern Manufacturing Systems Key to FDA Quality Initiative
More reliable operations would accelerate product development and prevent drug shortages.
Vaccine Development and Production Challenges Manufacturers
Scientists and industry experts seek effective preventive therapies to combat global disease.
FDA Issues Draft Guidance for Repackaging Biological Products
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
Hamburg's Tenure at FDA
The industry reacts to the departure of Commissioner Margaret Hamburg.
FDA Sets Policies to Enhance Drug Security and Safety
Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.
Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Politics and Patients to Shape Pharma in 2015
Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.
FDA Realigns Drug Inspection and Manufacturing Oversight
Operational changes at FDA and CDER aim to improve global market monitoring.
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.
Extending the Scope of Pharmacovigilance Comes at a Price
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Data Integrity Key to GMP Compliance
FDA demands accurate manufacturing and test information to ensure product quality.
Changes and Challenges for Generic Drugs
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
Industry Seeks Clearer Standards for Track and Trace
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
EU Steps Up Inspection Efforts
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.
Demand for New Vaccines Spurs Innovation
New formulations and expanded vaccine production are encouraged.
FDA and Manufacturers Seek a More Secure Drug Supply Chain
New identifiers and tracking requirements aim to block illegitimate products.
Quality by Design—Bridging the Gap between Concept and Implementation
As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
European Union Packaging Safety Features Come into Effect
Manufacturers are taking measures to comply with new package safety rules.
EMA Collaborates with HTA Assessment Networks
High technology assessments are having an impact on biosimilars development in Europe.
Opioid Regulation Challenges FDA and Manufacturers
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Congress Revises Rules for Drug Compounding and Supply-Chain Security
Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
