The Food and Drug Administration announced the availability of a draft guidance for industry entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report," prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The phone number for the Animal and Plant Health Inspection Service’s (APHIS) National Center for Import and Export (NCIE) centralized call center changed to 301-851-3300 on April 2. Callers with questions for NCIE will no longer need to search for a direct number to any of the many units within NCIE, APHIS said. By dialing the new number, callers can reach the NCIE unit they need.
The Animal and Plant Health Inspection Service issued emails April 2, 2012, announcing changes to some Plant Protection and Quarantine (PPQ) electronic manuals. While some changes are minor, other changes may affect the admissibility of the plant products, including fruits, vegetables, and flowers.
Congress has made little headway on IP legislation the White House said amid glowing enforcement statistics in it’s annual IP report released Friday. Despite offering at least 11 copyright bills this session, Congress was only able to enact two of the administration’s 20 IP legislative recommendations in the National Defense Authorization Act (NDAA), the report said.
Congress has made little headway on IP legislation, the White House said amid glowing enforcement statistics in its annual IP report released Friday. Despite offering at least 11 copyright bills this session, Congress was only able to enact two of the administration’s 20 IP legislative recommendations in the National Defense Authorization Act (NDAA), the report said.
The National Marine Fisheries Service (NMFS) is seeking information about nations whose vessels are engaged in illegal, unreported, or unregulated (IUU) fishing, or fishing that targets or incidentally catches sharks. The information will be used to identify nations pursuant to the High Seas Driftnet Fishing Moratorium Protection Act (Moratorium Protection Act), it said in a Federal Register notice.
The Food and Drug Administration has issued a final rule amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products. The final rule amends 21 CFR Part 211 by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons.
March 20 BroadbandBreakfast event on health IT and broadband, 8 a.m., Clyde’s Gallery Place, Washington -- http://xrl.us/bmxmi6
Broker Power is providing readers with some of the top stories for February 27 - March 2, 2012 in case they were missed last week.
U.S. Customs and Border Protection has posted an Automated Commercial Environment (ACE) user guide on In-Bond Authorization for rail and sea carriers. With the deployment of ACE e-Manifest: Rail and Sea (M1), rail and sea carriers will have the ability to create a list of authorized Type 2 In-Bond users in their ACE Secure Data Portal Accounts. This functionality will allow the carrier to control who can obligate their Type 2 custodial bonds (CBP Form 301). Although carriers are not required to utilize this functionality, carriers who choose to control access to their bonds have the ability to indicate the specific ports and lengths of time a carrier or broker is authorized to obligate their bond.