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
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
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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
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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’
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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
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,
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
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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
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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
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
Drugs
An updated FDA drug safety alert about the safety of some generic versions of angiotensin II receptor blocker (ARB) medicines that contain nitrosamine impurities (N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)), which are probable human carcinogens, has now dismissed significant safety concerns. “We were deeply concerned when we learned about
Drugs
FDA says that after the partial government shutdown ends it will extend or reopen the comment period on an 11/20/2018 Federal Register notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments” (Docket No. FDA-2018-N-3017). In the notice, FDA is
Drugs
FDA has lifted a partial clinical hold against MacroGenics and its Phase 1 monotherapy and combination studies of cancer drug MGD009, a B7-H3 CD3 bispecific DART molecule. New patient enrollment has been cleared to proceed with the trials, the company says. The hold was placed 12/7/2018 following