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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.

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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.

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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

FDA Issues Draft Guidance on Drug Development for Major Depressive Disorder

June 22, 2018

General toxicology studies should include a thorough evaluation of at least seven slices of the brain. Read More

FDA Issues Draft Guidance on Drug Development for Major Depressive Disorder

June 20, 2018

The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Read More

FDA Reports Challenging Year for Drug Shortages, Senate Requests Task Force

June 19, 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

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Research and Development
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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

FDA Issues Draft Guidance on Drug Development for Major Depressive Disorder

FDA Issues Draft Guidance on Drug Development for Major Depressive Disorder

FDA Reports Challenging Year for Drug Shortages, Senate Requests Task Force

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