Drugs
A year-long Bloomberg News inspection finds that FDA generic drug manufacturer inspections and enforcement actions have declined, even as approvals of generic drugs have increased in an effort to drive down drug prices through increased competition. The news service says that while concerns about quality control and data integrity
Drugs
FDA has sent University of Miami Reproductive and Fertility Center a just-posted Warning Letter citing it for significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products that were documented in a 7/2018 inspection. For example, FDA said the center failed to determine
Drugs
FDA has cleared a Cook Medical and Zelegent 510(k) for the Elevo Kit Snoring Intervention Device. The companies say the device’s delivery system allows placement of specially-shaped sutures that provide lift to the soft palate (elevoplasty) and then are naturally dissolved by the body. It is indicated
Drugs
FDA has granted Innate Pharma a fast track designation for IPH4102 and its use in treating adult patients with relapsed or refractory Sezary syndrome who have received at least two prior systemic therapies. The company describes the therapy as a first-in-class anti-KIR3DL2 antibody, developed for treating T-
Drugs
FDA commissioner Scott Gottlieb says the agency is undertaking additional activities to advance the opportunity to use real-world data (RWD) and real-world evidence (RWE) for the benefit of patients. In a 1/28 speech to the Bipartisan Policy Center Conference, he outlined the activities as: * supporting the seamless
Drugs
A 4/17-4/20/18 FDA inspection at Hangzhou Guoguang Touring Commodity Co., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A just-released 12/14/18 Warning Letter says specific violations were: failing to establish and follow adequate written procedures for
Drugs
Writing in a Washington Legal Foundation Legal Opinion Letter, Seton Hall University School of Law professor Howard Dorfman says that while the Centers for Medicare and Medicaid Services (CMS) may want to empower patients and lower prescription drug costs, its proposed rule to require drug companies to include a drug’
Drugs
An FDA notice says that for NDAs and BLAs transmitted to the agency during the partial government shutdown, sponsors will have a five-day window (until 2/1) to pay the required user fee. If the fee is paid within that five-day period, the receipt date will be the
Devices
FDA has cleared a MediPines 510(k) for the MediPines Gas Exchange Monitor, which is intended for real-time pulmonary parameters and insights to support rapid triage and treatment decisions for respiratory conditions. The device is designed to “integrate a comprehensive set of respiratory parameters and innovative indices analyzed from
Drugs
A JAMA Internal Medicine Research Letter by researchers from Harvard Medical School and elsewhere says that most of 686 respondents surveyed favor a relatively high bar for FDA approval of new drugs and prefer restrictions on off-label marketing. The survey was conducted to gauge the attitudes of internists, endocrinologists,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Guoguang Touring Commodity Co. Zhejiang, China (12/14): FDA inspected the firm 4/2018 and cited it for significant GMP violations for finished pharmaceuticals. For example, the firm
Drugs
FDA has issued a guidance, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, describing how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types under Section 745A(a) of the Federal
FDA Policy/General
FDA has yet to propose regulations to align its regulations on protection of human subjects with the revised Federal Policy for the Protection of Human Subjects (known as the Common Rule). Three Morgan Lewis attorneys write in an online blog post that the agency is aware of new inconsistencies between
Devices
FDA has extended by 30 days the comment period for a 12/2018 public workshop and a related white paper, Evaluating Whether Activities Are Servicing or Remanufacturing. Comments, which now are being accepted until 2/25, will be used by FDA to inform future guidance on the topic. The white
Drugs
FDA has denied an 8/2018 Pfizer petition urging FDA to tighten bioequivalence requirements for any ANDA submitter seeking approval for generic copies of its Premarin (conjugated estrogens) tablets. The petition sought to revise a 12/2014 draft guidance on methods for establishing active pharmaceutical ingredient sameness and bioequivalence for
Drugs
FDA has cleared a Masimo 510(k) for the measurement of respiration rate from the pleth (RRp) on the MightySat Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment. The MightySat Rx also measures functional oxygen saturation, pulse rate, perfusion index, and
Devices
FDA has approved an expanded use for AbbVie’s Imbruvica (ibrutinib) — combination use with Gazyva (obinutuzumab) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest approval expands Imbruvica’s use as a single agent or in combination with bendamustine and rituximab for adult
Devices
CDRH approved a record 106 novel devices last year, eclipsing the 40-year record it set in 2017 when 99 such devices were approved. The agency also granted 112 breakthrough device designation requests since the start of the program in 4/2015, and in 2018 it approved or cleared nine
Drugs
A “welcome back” email from CDER director Janet Woodcock to Center employees returning to work from the just-ended partial government shutdown instructs employees to “pick up the pieces and prioritize the work that has piled up. We can expect other parts of the agency and government to be doing
Drugs
FDA has approved an I-Mab Biopharma IND for TJC4, a human anti-CD47 monoclonal antibody for cancer immunotherapy. TJC4 is the third candidate from I-Mab’s proprietary discovery pipeline to be approved for clinical trials by the agency. Unlike other known CD47 antibodies under development, TJC4 works by
Drugs
FDA has approved a Promius Pharma NDA for Tosymra (sumatriptan nasal spray) 10 mg, indicated for the acute treatment of migraine with or without aura in adults. The company says the nasal spray is formulated using a proprietary novel excipient known as Intravail “to achieve blood levels similar to a
Devices
FDA has announced a 3/25-26 General and Plastic Surgery Devices Panel meeting to discuss topics concerning the benefit-risk profile of breast implants. The agency plans to publish a Federal Register notice and agenda on its Advisory Committee Calendar Web page 15 days in advance of the meeting.