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FDA
FDA Staff Disagreements May Be Cause of Delays in Implementation of PDUFA
According to a recent article from the Food and Drug Law Institute (FDLI), the Food and Drug Administration (FDA) in recent years…
FDA Draft Guidance on Safety Labeling Changes
When a pharmaceutical product or medical device is approved by the Food and Drug Administration (FDA), it must be given an…
Senate Special Committee on Aging: FDA and the Reform of the Medical Device…
Continuing the ongoing scrutiny surrounding the regulatory environment for medical devices in America, the Senate Aging Committee …
The Scope of Jurisdiction of DDMAC with Pharmaceutical and Device…
Recently, the Center for Business Intelligence (CBI) held an Evidenced Based Marketing and Promotion conference. One presentation…
FDA Guidance for Industry Clinical Pharmacogenomics: Premarketing…
Pharmacogenomics (PGx) broadly refers to the study of variations of DNA and RNA characteristics as related to drug response. Drug…
FDA Webinar How to Report Your Local Sales Rep
As we noted last year, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health…
FDA Regulations Doubles Review Time and Quadruples Trial Size for Diabetes…
Cardiovascular safety issues with a number of drugs led the Food and Drug Administration (FDA) in late 2008 to introduce new…
FDA Budget: Trying to Do Everything on Less Money
Recently, the Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration…
FDA Medical Device Innovation Initiative
Recently, the Food and Drug Administration (FDA) announced the "Medical Device Innovation Initiative," which proposes actions that…
FDA Guidance: Codevelopment of Two or More Unmarketed Investigational Drugs…
Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and…