Simplifying Global Compliance

Recommended Products

EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

Accelerating-generic-drug-development-130x160

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

Home » Topics » Pharmaceuticals » Research and Development

Research and Development
RSS

EMA Seeks Comments on Revised Guidelines for Antibiotic Trials

January 14, 2019

The European Medicines Agency released revised guidelines on Monday for stakeholder comment on evaluating drugs for treating bacterial infections. Read More

FDA Asked How to Unblind Blood Cancer Trials

November 15, 2018

Drugmakers asked the agency to clearly state how it wants sponsors to “un-blind” information. Read More

FDA Asked How to Unblind Blood Cancer Trials

November 8, 2018

Drug companies and a contract research organization are urging the FDA to sharpen its recommendations on how to reveal to blood cancer patients whether they’re taking placebos or the real thing in clinical trials. Read More

Nervous System Drugs Lag in Development, Approvals: Tufts

October 10, 2018

Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More

Phase III Trial Costs Estimated at $19 Million

September 25, 2018

The researchers identified three key elements that were likely to drive up costs. Read More

Phase III Trial Costs Estimated at $19 Million

September 24, 2018

It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found. Read More

Nervous System Drugs Lag Behind in Development, Approvals, Tufts Reports

September 13, 2018

CNS drugs were approved at a 6 percent faster clip than other drugs between 2012 and 2017, according to the report, but it’s unclear whether that trend will last. Read More

Nervous System Drugs Lag Behind in Development, Approvals, Tufts Reports

September 12, 2018

Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More

EMA Updates Drug Development Advice for Inflammatory Diseases

August 9, 2018

The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More

EMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases

July 25, 2018

The agency discourages using the Crohn’s Disease Activity Index (CDAI) to assess efficacy because of questions about its reliability and validity. Read More

EMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases

July 24, 2018

The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More

FDA Reports Challenging Year for Drug Shortages

July 11, 2018

In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Read More

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA
Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Recommended Products

EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Events

Implement a Best Practice Medical Device Change Control Process: Avoid Common Pitfalls

Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

Demystifying Cloud Systems and Validation Practices for Life Sciences

FDA Adverse Event Reporting System (FAERS): Practical Insights to Avoid 483s

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

Increase Compliance, Reduce Risk with Integrated Digital Solutions: Create a Connected System and...

Editor's Picks

Korean Firm Earns CE Mark for Respiratory Virus Detection Kit

Federal Prosecutors Criminally Probe Drugmakers Compliance With Controlled Substances Act

Research and Development
RSS

EMA Seeks Comments on Revised Guidelines for Antibiotic Trials

FDA Asked How to Unblind Blood Cancer Trials

FDA Asked How to Unblind Blood Cancer Trials

Nervous System Drugs Lag in Development, Approvals: Tufts

Phase III Trial Costs Estimated at $19 Million

Phase III Trial Costs Estimated at $19 Million

Nervous System Drugs Lag Behind in Development, Approvals, Tufts Reports

Nervous System Drugs Lag Behind in Development, Approvals, Tufts Reports

EMA Updates Drug Development Advice for Inflammatory Diseases

EMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases

EMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases

FDA Reports Challenging Year for Drug Shortages

Recommended Products

Events

Editor's Picks

Research and Development RSS

Research and Development
RSS