At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
12/21/2023
/ Artificial Intelligence ,
Birth Control ,
Cannabidiol (CBD) oil ,
Digital Health ,
Drug & Alcohol Abuse ,
DSCSA ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Opioid ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Reauthorization
Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more
7/13/2017
/ Comment Period ,
Delays ,
Distributors ,
Drug Safety ,
DSCSA ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Identifiers ,
Product Packaging ,
Public Comment ,
Reporting Requirements ,
Security Controls ,
Supply Chain
Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more
10/12/2015
/ Covered Entities ,
Databases ,
Distributors ,
DSCSA ,
Due Diligence ,
Food and Drug Administration (FDA) ,
Licenses ,
Pharmaceutical Distribution ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Third-Party Service Provider ,
Wholesale
Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more