Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 27 Aug 2018
FDA mandated listing of drug prices in ads would flunk legal and constitutional tests
27 August 2018 - We've read with amusement the recent, overblown claims of some constitutional-law commentators and even U.S. Supreme Court ...
Posted by Michael Wonder on 22 Aug 2018
Statement by FDA Commissioner on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...
Posted by Michael Wonder on 25 Jul 2018
FDA publishes list of surrogate outcomes used in drug approvals
25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 16 Jul 2018
EMA’s proactive publication of clinical data a success
16 July 2018 - First report on unprecedented transparency policy shows high user satisfaction. ...
Posted by Michael Wonder on 19 Jun 2018
Modernising the orphan designation process
19 June 2018 - The EMA has launched a new secure online portal for orphan designationExternal link icon applications. ...
Posted by Michael Wonder on 06 Jun 2018
Clinical trial participants’ views of the risks and benefits of data sharing
7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...
Posted by Michael Wonder on 29 May 2018
EMA publishes agenda for 28-31 May CHMP meeting
28 May 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 May 2018
Janssen questions literature review on biosimilar switching studies as authors defend it
22 May 2018 - Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is ...
Posted by Michael Wonder on 20 May 2018
Requiring prices in drug ads: would it do any good? Is it even legal?
19 May 2018 - A commercial for Neulasta, a drug that reduces the risk of infections after chemotherapy. If President Trump ...
Posted by Michael Wonder on 18 May 2018
FDA looking at ways to include price info in drug ads, Gottlieb says, as questions loom
18 May 2018 - The commissioner of the FDA, Scott Gottlieb, said a proposal to have pharmaceutical companies include drug ...
Posted by Michael Wonder on 16 May 2018
FDA explores requiring drug price disclosures in commercials
15 May 2018 - Drug companies on Tuesday claimed the Trump administration may not have the legal authority to make ...
Posted by Michael Wonder on 15 May 2018
FDA to name companies accused of hindering generic drug development
14 May 2018 - On Thursday, the FDA plans to start publishing the names of pharmaceutical companies that have been ...