Medical Product Communication, Part One: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer...
Last Stop: President Obama – 21st Century Cures Bill Passes Through the Senate and Heads to Obama for Signature
After passing through the House of Representatives with an extraordinary amount of support last week, the 21st Century Cures Act headed to the Senate on Monday, December 5th. On Wednesday, December...
#6: Expedited Programs for Serious Conditions – Drugs and Biologics
In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.” The intention of the document was to provide drug makers with an...
#8: Special Protocol Assessment
The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give...
Top Ten FDA Guidance Documents That You Should Know
There are a number of laws, regulations, and guidance documents ruling the pharmaceutical and biotechnology industries. Laws are passed by Congress and must be followed by the FDA. The Agency then...
FDA Issues 67 New & Revised Bioequivalence Study Recommendations for Generic Drug Makers
In order for a generic drug to be approved by the FDA, the drug maker must prove that the product is pharmaceutically equivalent to its reference listed drug (RLD). There are many different types of...
FDA Redefines the Term “Healthy” in Food Labeling
On Wednesday, September 28th, the FDA issued a final guidance document regarding the inclusion of the term “healthy” on the labels of food products. The guidance, entitled “Use of the Term ‘Healthy’...
Self-Identification 101: Everything You Need to Know About FDA’s Self-Identification Requirements for Generic Drug Facilities, Sites, & Organizations
On Thursday, September 22, FDA issued a guidance document, entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document was published with the intention of...
FDA Releases Regulatory Science Priorities for Medical Devices in 2017
On Thursday, September 22nd, the FDA’s Center for Devices and Radiological Health (CDRH) released its regulatory science priorities for fiscal year 2017. CDRH & Regulatory Science According to CDRH,...
FDA Updates Requirements Regarding Health Document Submissions for Tobacco Products
On Friday, September 9th, FDA announced the availability of a revised draft guidance, entitled “Health Document Submission Requirements for Tobacco Products.” The document was initially published in...