On July 25, 2014 FDA issued revised draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This revised draft guidance Continue reading
On June 2nd, 2014 the FDA announced the launch of openFDA, a new initiative designed to make accessing important public health data collected by the FDA easier for Continue reading
The FDA has released a guidance for industry titled ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers. This guidance provides answers to questions from the Continue reading
Regxia Inc. is pleased to advertise that they will be exhibiting with the Drug Information Association (DIA) at their 50th Annual Meeting in San Diego from June 15-19. Regxia will be occupying Booth 1944 and Continue reading
On May 15, 2014 the FDA released four revised final versions of “documents that support making regulatory submissions in electronic format using the Continue reading
On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.
The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading
March 2014 saw the FDA release a Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. Interestingly, the FDA make note that Continue reading
On April 3, 2014 at 12:00 EST Regxia Inc. launched its first corporate rebranding, encompassing a refinement of the company’s logo and a re-launching of the corporate websites. Regxia’s Vice President and co-founder Lori Steinhoff – de Munnik, RAC sees “Regxia Inc.’s rebranding and website re-launch as Continue reading
In order to provide industry with guidance on how to meet the BA and BE requirements as they apply to dosage forms intended for oral administration the FDA has published this draft guidance for general considerations. The guidance applies to Continue reading
In June 2006 the FDA released its Guidance for Industry: Antiviral Product Development – Conducting and Submitting Virology Studies to the Agency available here: http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0183-gdl0002-01.pdf. Since its release the FDA has developed three attachments (available here: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124470.htm) with the fourth, DRAFT Guidance for Submitting HIV-1 Resistance Data currently open for comment.
The purpose of this new draft guidance is to Continue reading