News

Latest News | 12 April 2013

Path Cleared for Potential Parkinson's Treatment as FDA Advises Company to Skip Ph III Study

0 Likes

If US regulators have a reputation with the pharmaceutical industry, it's generally been for putting up roadblocks to product approval in the way of requiring further clinical studies to assuage Read More...

---

Latest News Regulatory Update | 4 March 2013

China FDA Report Claims Reduced Drug Lag

0 Likes

A new report released by China's State Food and Drug Administration's (FDA) Center for Drug Evaluation shows that review and approval times for clinical trial applications for most drugs averages Read More...

---

Latest News | 12 February 2013

Woodcock: FDA to Consider Approving Some Drugs Using Just One Phase I Clinical Trial

1 Likes

Some innovative, high-need therapies could reach the market using just Phase I clinical trials data, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Read More...

---

Latest News | 14 January 2013

NIH Announces Support for Alzheimer's Clinical Trial, Regulatory Science Initiative

1 Likes

The National Institutes of Health (NIH) has announced the launch of four new clinical trials, part of a long-running initiative that hopes to find new treatments for—and maybe even entirely Read More...

---

Latest News | 3 October 2012

Pediatric Challenges Focus of Amended EMA Guideline on Lipid Disorders

0 Likes

A new pediatric addendum from the European Medicines Agency (EMA) is aimed at highlighting unique challenges facing the development of treatments for pediatric patients with lipid disorders.Primary, Read More...

---

Latest News | 1 October 2012

FDA Guidance Establishes Specific Recommendations for Ear Infection Therapies

0 Likes

A new guidance document released by the US Food and Drug Administration (FDA) is intended to assist sponsors developing therapies to treat bacterial ear infections.The guidance, Acute Bacterial Otitis Read More...

---

Latest News | 24 September 2012

Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

0 Likes

Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of Read More...

---

Latest News | 27 August 2012

Pilot Trial Skipped, Pivotal Trials Ready for Diabetes Device

0 Likes

The US Food and Drug Administration is allowing GI Dynamics to move directly into pivotal clinical trials with its diabetes treatment device, according to a story from Mass High Tech. Read More...

---

Latest News | 24 August 2012

FDA Places Clinical Hold on BMS Drug after Emergence of Unexpected Adverse Events

0 Likes

A phase II drug compound under development by Bristol-Myers Squibb for the treatment of hepatitis C has been discontinued after at least one patient death and multiple hospitalizations for adverse Read More...

---

Latest News | 23 August 2012

Researchers: FDA Needs to Take More Control over Postmarketing Studies

0 Likes

The manner in which US regulators assess the safety of prescription drug products after approval is in serious need of reform, opines a trio of researchers writing in the New England Journal of Read More...

---