FDA Policy/General
A Senate appropriations subcommittee has voted to advance FDA’s fiscal year 2022 budget that would give the agency a $200 million (6%) spending boost. The subcommittee approved FDA’s total funding at $3.414 billion, which (XXX SPELLING XXprovides increases for food (XXX DELETE XXand medical product safety activities.
FDA Policy/General
Federal Register notice: FDA is denying a request for a hearing submitted by Vithal K. Patel and issuing an order debarring him for one year from providing services in any capacity related to an approved or pending drug product application. FDA bases this order on a finding that Patel was
FDA Policy/General
Federal Register notice: FDA is denying Belen G. Ngo’s request for a hearing and is issuing an order debarring her for five years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that
FDA Policy/General
Federal Register final rule: FDA has issued a final rule to amend its medical product “intended use” regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act. The rule also withdraws
FDA Policy/General
Device User Fee Rates for FY 2022 7/30/2021 Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022. The standard fees are as follows: PMA or efficacy supplement ($374,858); panel-track supplement ($281,143); de novo classification request ($112,457); 180-
FDA Policy/General
Ariad Pharmaceuticals has agreed to be acquired by Takeda Pharmaceutical Co. in a deal valued at about $5.2 billion. Takeda will pay $24 in cash for each Ariad share owned for a premium of about 75% over Ariad’s recent closing price. Astellas Pharma has completed an acquisition of
FDA Policy/General
Federal Register notice: FDA has set the medical device user fee rates for fiscal year 2022. The standard fees are as follows: PMA or efficacy supplement ($374,858); panel-track supplement ($281,143); de novo classification request ($112,457); 180-day supplement ($56,229); real-time supplement ($26,240); and
FDA Policy/General
Federal Register notice: FDA has announced a 10/7 Antimicrobial Drugs Advisory Committee meeting. It is scheduled to discuss a Takeda Pharmaceuticals NDA for maribavir oral tablets for treating adults with post-transplant cytomegalovirus infection, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Request for Samples and Protocols” (OMB Control Number 0910-0206). The collection supports agency regulations giving it the responsibility to prescribe standards designed to ensure the safety, purity, and potency of biological products and to ensure that
FDA Policy/General
Federal Register notice: FDA determines that Eli Lilly’s Ceclor CD (cefaclor extended-release tablets) 375 mg and 500 mg were not withdrawn from sale for reasons of safety or effectiveness, except for the indication “secondary bacterial infections of acute bronchitis.
FDA Policy/General
Federal Register notice: CDER and CBER are announcing the effective date of 9/15 for using Electronic Common Technical Document (eCTD) validations referenced in FDA’s “Technical Rejection Criteria for Study Data.” FDA says that submissions that are not submitted electronically and electronic submissions that are not in a format
FDA Policy/General
Federal Register notice: FDA has determined that Bausch Health America’s Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA can continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.” The document is intended to help sponsors in developing anti-rabies virus monoclonal antibody cocktails as an alternative to anti-rabies virus immunoglobulin as the
FDA Policy/General
Federal Register notice: FDA has announced the generic drug user fee rates for fiscal year FY 2022. The rates are: ANDA ($225,712), drug master file ($74,952), domestic API facility ($42,557), foreign API facility ($57,557), domestic finished dosage form facility ($195,012), foreign finished dosage form facility
FDA Policy/General
Federal Register notice: FDA has issued a five-year debarment order against Justin Ash due to his felony conviction for illegal importation of a drug or controlled substance through his internet-based business entity known as both DRC and Domestic RCS. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2022 user fee rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. The rates are: small business establishment fee ($5,824), the non-small business establishment fee ($18,999)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.” The document provides product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence to support ANDAs for olodaterol hydrochloride; tiotropium bromide inhalation sprays. To view the notice,
FDA Policy/General
Federal Register notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2022. The initial and annual biological product development fee is $57,184. The fee for an application requiring clinical data is $1,746,745, and the fee for an application not requiring clinical data is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Reporting — 21 CFR Part 803” (OMB Control Number 0910-0437). The collection supports FDA regulations and FDA’s Medical Device Reporting program that require reporting of device adverse events. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the animal drug user fee rates and payment procedures for fiscal year 2022. The fees are: $580,569 for an animal drug application; $290,284 for a supplemental animal drug application for which safety or effectiveness data are required; $10,787 for an annual
FDA Policy/General
Federal Register notice: FDA has announced a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss toxicity risks of adeno-associated virus vector-based gene therapy products. Specifically, they will discuss oncogenicity risks due to vector genome integration and safety issues identified
FDA Policy/General
Federal Register notice: FDA has rescinded a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determined no longer require premarket notification. The Department and FDA now have determined that the seven types of Class 1 surgeon’s gloves and patient examination gloves listed