Clinical Research Solutions
Job Description Great opportunity for someone looking to launch their career in the sales or administrative fields! Prior experience is not required, but may be helpful. The Weinberg Group, the...
Clinical Research Solutions
Job Description The Weinberg Group, the leading FDA consultancy, is expanding and seeking an experienced CMC professional to add to our existing capabilities. Qualified candidates must have at least...
Clinical Research Solutions
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Clinical Research Solutions
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...
Clinical Research Solutions
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
Clinical Research Solutions
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Clinical Research Solutions
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
Regulatory Sciences
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
Clinical Research Solutions
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Clinical Research Solutions
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...