FDA Policy/General
FDA has approved Revivicor’s intentional genomic alteration (IGA) in GalSafe pigs for use as food and human therapeutics. “This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses,” an FDA release says The
FDA Policy/General
Notice Corrected on Drug Development Tools Guide Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view
Devices
FDA has granted ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treating patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The designation is based on recent positive data from the RADIANCE-HTN TRIO study, according to the company.
Devices
FDA has posted three new guidances for device makers to use under its Safety and Performance-Based Pathway. Manufacturers have the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as its predicate. The guidance Spinal Plating Systems – Performance Criteria for Safety
FDA Policy/General
Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. The applicants also waived their opportunity for a hearing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devices. Electronic or written comments can be submitted until 2/16/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2022. To view the notice, click here.
Drugs
FDA has granted Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pain. The company says it is currently enrolling patients with this condition in a Phase 2 proof-of-concept study and it is preparing to initiate a second Phase 2 clinical
Drugs
Sanofi and GlaxoSmithKline have announced a delay in their Covid-19 vaccine program to improve immune response in older adults. “Phase 1/2 study interim results showed an immune response comparable to patients who recovered from Covid-19 in adults aged 18 to 49 years, but a low immune response
Biologics
FDA late Friday (12/11) granted an emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. The agency action comes after the White House reportedly ordered FDA commissioner Stephen Hahn to grant the EUA or submit his resignation by the end of the day. “Today’s action follows
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, 400 mg. The withdrawal decision is based on FDA concerns about certain phthalate esters, including dibutyl phthalate (DBP), being developmental and reproductive toxicants in laboratory animals. Asacol (mesalamine) contains DBP
FDA Policy/General
Federal Register notice: FDA has announced the names of the members who will serve on its fiscal year 2020 Performance Review Board. The board is intended to provide fair and impartial review of staff’s Senior Executive Service, Senior Professional, 21st Century Cures Act, and Title 42(f) performance appraisals,
Drugs
The International Council on Harmonization (ICH) says the electronic Common Technical Document (eCTD) v4.0 question-and-answer and specification change request document v1.4 reached Step 4 of the ICH process this month. An ICH statement says the document is a summary of questions received by the eCTD implementation
Devices
FDA has authorized LabCorp’s Pixel Covid-19 Test Home Collection Kit for direct-to-consumer use without a prescription by an individual age 18 and older. An agency statement says the kit allows individuals to self-collect a nasal swab at home and send the sample to LabCorp for
Drugs
At the 10/13 meeting of the PDUFA 7 FDA and the industry negotiation regulatory decision tools subgroup, FDA discussed the Complex Innovative Trial Design (CID) program and its PDUFA 6 pilot. A meeting summary says FDA discussed a need to build upon the current pilot to provide time, expertise,
Drugs
AvKare (Pulaski, TN) has withdrawn one lot of sildenafil 100 mg tablets and one lot of trazodone 100mg tablets due to a product mix-up that led them to be inadvertently packaged together during bottling at a third-party facility. Unintentional consumption of sildenafil may pose serious health risks because
Drugs
Torrent Pharmaceuticals has recalled one lot of anagrelide capsules due to a dissolution test failure detected during routine quality testing. “Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body,” a recall notice says. “For seriously ill patients with
Drugs
Oblato says that in discussions with FDA officials on the company’s plan for a Phase 1/2 clinical trial to start developing a new treatment for diffuse intrinsic pontine clioma (DIPG), a rare pediatric disease, using the company’s OKN-007, the agency gave consent for matters such as
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a healthcare professional e-mail for Azurity Pharmaceuticals’ Xatmep makes false or misleading claims and/or representations about the drug’s risks and efficacy. An 11/24 Notice of Violation says the violations are especially concerning from a public health perspective
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. Panel members voted 17 to 4 that: based on the totality of scientific evidence available, the benefits of the vaccine outweigh its risks for use
Drugs
FDA has granted X4 Pharmaceuticals a rare pediatric disease designation for mavorixafor for treating WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene. The company says the drug is currently being investigated in a global pivotal Phase