FDA Policy/General
More details are trickling out of FDA on the package of legislative proposals that were included in the Biden Administration’s fiscal year 2023 budget proposal for the agency 3/28 (see earlier story), including expanded authority to enhance remote regulatory assessments that were widely used during the Covid-19
FDA Policy/General
Federal Register final rule: FDA is amending the medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements as it is editorial
FDA Policy/General
Federal Register final rule: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2021, 11/2021 and 12/2021. FDA is also making available the basis of approval and environmental review documents, where applicable.
FDA Policy/General
Senator Rick Scott (R-FL) is urging FDA to fill vacant management posts at CDER and CBER because, he says, “FDA is too important an agency, and too large and complex an organization, for it to operate under temporary leadership.” In a 3/22 letter to FDA commissioner Robert Califf,
FDA Policy/General
FDA is requesting a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of President Biden’s just-released budget request. The proposed budget total would amount to $8.4 billion, which includes $3.7 billion in budget authority – an almost 10% increase
FDA Policy/General
Senate Homeland Security and Governmental Affairs Committee chairman Gary Peters (D-MI), has introduced legislation to help prevent conflicts of interest, such as the one Congress has been investigating — FDA’s consulting contracts with McKinsey & Co. on regulatory actions involving opioids while the company was also advising opioid maker
FDA Policy/General
Drug User Fee Notice Correction 3/25/2022 Federal Register notice: FDA is correcting an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” The notice was published with errors, which do not have an impact on the previously published user fee rates but are
FDA Policy/General
Thermo Fisher Scientific has agreed to acquire Patheon, a pharmaceutical contract development and manufacturing organization, for $7.2 billion, which includes the assumption of about $2.0 billion in debt. WuXi AppTec has completed its acquisition of HD Biosciences, a leading biology-focused preclinical drug discovery contract research organization. HD
FDA Policy/General
DEVICES Becton, Dickinson and Co. has received FDA 510(k) clearance for a new insulin infusion set with BD FlowSmart technology, which features a unique side-ported catheter, which has been developed to improve the insulin flow and reduce the number of flow disruptions, according to the company. It adds
FDA Policy/General
Federal Register notice: FDA is correcting an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” The notice was published with errors, which do not have an impact on the previously published user fee rates but are corrected in this notice for clarity. To view
FDA Policy/General
The Senate 3/24 passed the “Cannabidiol and Marijuana Research Expansion Act” that is intended to ensure that research on cannabidiol (CBD) and other potentially beneficial marijuana-derived substances is based on sound science while simultaneously reducing the regulatory barriers associated with conducting related research. Introduced by Sens. Chuck Grassley
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct a study entitled “Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescription Drug Websites.” A recent OPDP analysis of DTC Web sites for accelerated approval products found that 21% contained disclosures about the accelerated approval that used language
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requested the action. The company said the accelerated-approval drug, which is used in treating multiple myeloma, was not shown to be effective in a confirmatory postmarketing study because it was
FDA Policy/General
Federal Register notice: FDA has renewed its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until the 3/23/2024. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.” The document describes FDA’s compliance policy regarding requirements that are now applicable to ophthalmic drugs packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic
FDA Policy/General
Federal Register notice: FDA is amending the standing advisory committees’ regulations to change the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee to Obstetrics, Reproductive and Urologic Drugs Advisory Committee. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 4/6 Vaccines and Related Biological Products Advisory Committee meeting to discuss considerations for use of Covid–19 vaccine booster doses and the process for Covid–19 vaccine strain selection to address current and emerging variants. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Irfanali Nisarali Momin for five years from importing or offering for import any drug into the U.S. The debarment is based on Momin’s felony conviction for illegally importing misbranded drugs from China that he marketed for male enhancement. To
FDA Policy/General
Federal Register notice: FDA has updated its current listing of medical devices that have received an Emergency Use Authorization during the Covid-19 public health emergency. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit comments that will assist the agency in determining how best to prioritize the addition of maximum daily exposure (MDE) information for inactive ingredients that do not currently include MDE information in CDER’s Inactive Ingredient Database (IID) and whether to
FDA Policy/General
Federal Register notice: FDA has corrected a 3/10 notice on a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” It now reflects that either electronic or written comments can be submitted until 5/9. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has corrected a 3/10 notice on a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” It now reflects that either electronic or written comments can be submitted until 5/9. To view the notice, click here.