FDA Policy/General
Federal Register notice: FDA has announced a 6/22 virtual public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from FDA on the five-year plans for drug, biosimilar and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Altaire Pharmaceuticals, Aquebogue, NY (3/12): FDA inspected the firm 4/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish an adequate
FDA Policy/General
Boston Scientific has agreed to acquire NxThera, a privately-held company based in Maple Grove, MN for $306 million upfront and an additional $100 million in potential commercial milestone payments over the next four years. The transaction gives Boston Scientific the Rez?m, a treatment system for men with symptoms
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to the C vid-19 public health emergency. The guidances have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB. They are: * National Panel of Tobacco Consumer Studies * Study of Oncology Indications in Direct-to-Consumer Television Advertising * Premarket Approval of Medical Devices * Hazard Analysis and Critical Control Point Procedures for the Safe
FDA Policy/General
Federal Register notice: FDA is announcing a 6/4-5 public Web conference to discuss the International Council for Harmonization’s (ICH's) good clinical practice guidelines. The conference, “Stakeholder Engagement on ICH E6:Guideline for Good Clinical Practice,” is intended to capture stakeholder experiences with current ICH E6
FDA Policy/General
Federal Register notice: FDA has issued a final guidance on “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.” The document describes the agency’s current recommendations regarding Phase 2 or Phase 3 trials for drugs or biological products under development for treating or preventing Covid-19. It
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “General Administrative Practice and Procedures” (OMB Control Number 0910-0191). The collection is being revised to consolidate related activities discussed in agency guidance to improve the efficiency of its operations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.” The document describes four policies intended to help sponsors develop Covid-19 tests during the public health emergency. Two of these address policies for accelerating the development of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection extension entitled “Electronic Products” (OMB Control Number 0910-0025). FDA’s regulations give it authority to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). The collection is being revised to include reference to the guidance entitled “Pharmacy Compounding of Human
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 16 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))” (OMB Control Number 0910-0471). The collection supports FDA regulations that require manufacturers to report medical device-related deaths, serious injuries, and malfunctions. It also requires
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)” (OMB Control Number 0910-0616). The data collection relates to adherence to the legal requirements for submissions to the clinical trials registry and
FDA Policy/General
FDA commissioner Stephen Hahn, CDC director Robert Redfield and NIH National Institute of Allergy and Infectious Diseases director Anthony Fauci are under quarantine after being exposed to an unidentified White House staffer who tested positive for Covid-19. The three members of the White House Coronavirus Task Force are scheduled
FDA Policy/General
Federal Register notice: FDA has announced the approval withdrawal of seven ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to the coronavirus disease 2019 (Covid-19) public health emergency. A 3/25 Federal Register notice outlined the availability of such guidances and those in this notice have been issued in accordance with that process. Additionally, the guidance documents have
FDA Policy/General
ANI Pharmaceuticals has signed definitive agreements to acquire a portfolio of generic products and other assets from Amneal Pharmaceuticals and Impax Laboratories. The transaction is the result of a divestiture process mandated by the Federal Trade Commission in connection with Amneal Pharmaceutical’s proposed business combination with Impax Laboratories. The
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled “Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.” The document is intended to assist sponsors in all phases of the clinical development of drugs and biological products to treat or prevent cytomegalovirus disease in patients who have undergone
FDA Policy/General
An 11/4-11/21/19 FDA inspection at the University of Kentucky laboratory conducted by the FDA Office of Bioresearch and Monitoring Operations found that activities and procedures related to the laboratory’s participation in nonclinical laboratory studies of the Novalung System did not comply with applicable regulations. A
FDA Policy/General
Federal Register notice: FDA has announced that it is abandoning a 9/2017-published approach that would have enabled device sponsors to obtain marketing authorization for their products labeled for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue