Drugs
FDA has issued a guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products, to encourage manufacturers of medically necessary drug products and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production
Devices
The Healthcare and Public Sector Coordination Council Joint Cybersecurity Working Group, of which FDA is a member, has produced a Joint Security Plan (JSP) to address cybersecurity challenges in using software-based medical technologies. The document says the challenges include but are not limited to transparency and disclosure between vendors
Drugs
FDA commissioner Scott Gottlieb says the agency is developing a pilot program to help patients navigate the expanded access protocol to receive access to drugs that have not yet been approved. Speaking on a wide-ranging American Society of Clinical Oncology podcast, Gottlieb said the pilot will enable agency personnel
Drugs
FDA has granted Merck a breakthrough therapy designation for its V114 investigational 15-valent pneumococcal conjugate vaccine, indicated for preventing invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. V114 is also under development for preventing IPD in adults. Both
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to “ensure that the Orange Book provides the greatest benefit to patients and providers, and generic drug developers. We want to make sure it provides as much utility as possible to aid manufacturers as they allocate resources towards the development
Devices
FDA has approved a Kurin 510(k) for its Kurin PIV18 peripheral IV (PIV) configuration with an extension set, which is intended for use with infusions. Many blood cultures are taken via direct venipuncture. By adding an extension set to a previously-available PIV product, nurses can leave the set
Drugs
Tris Pharma has recalled three lots of infants’ ibuprofen concentrated oral suspension, 50 mg per 1.25 mL, because the products have been found to potentially have higher concentrations of ibuprofen. “There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug,
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