FDA Policy/General
Federal Register notice: FDA has announced that two information collection proposals — “Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution” and “Blood Establishment Registration and Product Listing” have been approved by the Office of Management and Budget (OMB). The information collections and have been assigned OMB
FDA Policy/General
Federal Register notice: FDA has announced the availability to license an agency invention for “Solid-Phase Purification of Synthetic DNA Sequences,” a high-throughput method for purifying full-length phosphorothioate and native DNA sequences. The method comprises a modified silica gel that enables capture of DNA sequences functionalized with a
FDA Policy/General
LabCorp has acquired the assets of the Mount Sinai Health System Clinical Outreach Laboratories, and LabCorp is now available to provide comprehensive laboratory services to physicians and patients that previously used the outreach laboratory. Xenon Pharmaceuticals has acquired from 1st Order Pharmaceuticals XEN1101, a potassium channel modulator for the potential
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions — 21 CFR Part 60 — OMB Control Number 0910–0233.” Such petitions should provide sufficient facts, including dates if possible, to merit an investigation by FDA
FDA Policy/General
Federal Register notice: FDA has announced a 5/18 joint Pediatric Advisory Committee and Pediatric Ethics Subcommittee meeting to discuss a referral by an Institutional Review Board of a clinical investigation that involves children and FDA-regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Good Laboratory Practice Regulations for Nonclinical Studies — 21 CFR Part 58 OMB Control Number 0910–0119.” The regulations specify minimum standards for proper safety testing and they contain sections on facilities, personnel, equipment, standard operating procedures, test
FDA Policy/General
Federal Register notice: CDER and CDRH have announced a two-day (5/9-10) public conference entitled “FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.” The conference is intended to address questions from small manufacturers of drug or medical devices who want to learn about
FDA Policy/General
The Senate Health, Education, Labor & Pensions Committee has voted 14 to 9 to report out and send the nomination of Scott Gottlieb as the next FDA commissioner to a floor vote. Gottlieb previously served as deputy FDA commissioner during the George W. Bush administration. Two Democrats joined Republicans in
FDA Policy/General
Federal Register notice: FDA has announced a 7/10 public workshop entitled “Sentinel Training at FDA” that is intended to provide training on the kinds of questions that can be asked using health care claims data under the Sentinel System. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Marathon Pharmaceuticals for its recently approved Emflaza (deflazacort) tablets and oral suspension for treating patients age five and older with Duchenne muscular dystrophy (DMD). An agency news release says that Emflaza is a corticosteroid that works by decreasing inflammation
FDA Policy/General
Federal Register notice: FDA is seeking comments on a report submitted by Duke Clinical Research Institute evaluating pediatric studies of ampicillin that were conducted under a written request for pediatric data to determine the safe use as a first line antibiotic therapy for certain infections. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection on “Certification of Identity for Freedom of Information Act (FOIA) and Privacy Act Requests — OMB Control Number 0910.” The new form is intended to provide the agency with data necessary to identify an individual requesting a particular record
FDA Policy/General
The Senate Health, Education, Labor & Pensions (HELP) Committee has postponed a vote (see earlier story) until 4/27 on Scott Gottlieb to be the next FDA commissioner. The previous voted was scheduled for 4/26, but committee chairman Lamar Alexander (R-TN) postponed it due to a scheduling issue
FDA Policy/General
Federal Register notice: FDA, the National Science Foundation and Department of Homeland Security, Science and Technology have announced a public workshop (5/18-19) entitled “Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis.” The workshop is intended to discuss the current state of regulatory science in the field of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act — OMB Control Number 0910–0679.” The guidance describes the agency’s interpretation
FDA Policy/General
A white paper issued by two Venable attorneys reviews President Donald Trump’s executive order on reducing regulations and controlling regulatory costs, saying it represents the greatest potential change in federal regulatory policy since a 1981 executive order issued by President Ronald Reagan. The paper explains what the order does
FDA Policy/General
Federal Register notice: CDER has announced its continuation of the Regulatory Project Management Site Tours and Regulatory Interaction program, and it is inviting pharmaceutical companies interested in participating to contact the Center. Under the program, CDER regulatory project managers can observe drug manufacturing and other facility operations to better understand
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of two NDAs held by Guerbet Group after being notified that the products were no longer marketed. The affected products are Hexabrix (ioxaglate meglumine and ioxaglate sodium) injection and Oxilan-300 and Oxilan-350 (ioxilan) injection. To view the notice, click here.
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Divi’s Laboratories Ltd. Andhra Pradesh, India (4/13): FDA inspected the firm in December and found significant GMP deviations for active pharmaceutical ingredients (APIs). The agency says the
FDA Policy/General
Federal Register notice: FDA has announced a 5/17 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee meeting where panel members will review a TransMedics PMA for the Transmedics Organ Care System — Lung System. The portable organ perfusion, ventilation, and monitoring device is intended to preserve donor
FDA Policy/General
Federal Register notice: CDER has announced a one-day (6/15) public symposium on “Safe Use Symposium: A Focus on Reducing Preventable Harm From Drugs in the Outpatient Setting.” The symposium is intended to discuss sources of preventable harm from drugs in the outpatient setting and to stimulate the exchange
FDA Policy/General
Federal Register notice: FDA has announced a 5/17 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in an open session to discuss considerations for evaluating Respiratory Syncytial Virus vaccine candidates in seronegative infants. To view the notice, click here.