FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Human Food By-Products For Use As Animal Food. It helps domestic and foreign facilities that are required to register as food facilities under the FD&C Act, because they manufacture, process, pack, or hold human
Drugs
With the huge outcry from media, parents and healthcare professionals on Mylan increasing its EpiPen (epinephrine injection) auto-injector by 400%, lawmakers have written FDA asking what it can do to ensure approval of competitive alternatives. “We are concerned that Mylan has not faced much competition for its product,” the
Drugs
FDA has posted a guidance on “ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits” — that is intended to help applicants preparing to submit ANDAs and prior approval supplements for approval of a new strength of a drug product. The guidance highlights deficiencies about impurities that may
Drugs
Harvard Medical School researchers Arnold Kesselheim, Jerry Avorn, and Arneet Sarpatwarni say that prescription drugs are priced in the U.S. “primarily on the basis of what the market will bear.” Writing in a Journal of the American Medical Association Special Communication (subscription required), the three say that the much
Drugs
A California federal court has rejected a class action case settlement proposed by Similasan Corp. that has been accused of engaging in false and deceptive labeling of their homeopathic products, among other things. Texas attorney general Ken Paxton, who opposed the settlement along with seven other state attorneys general, says
Devices
FDA has cleared an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes. The interbody fusion device is made of the company’s proprietary medical grade silicon nitride ceramic. The recently cleared sizes allow for a wider range of patient anatomies as well as “greater stability as the shape
Drugs
The Stericycle Recall Index for the second quarter of 2016 shows that drug recalls are up from the first quarter, but still well below historical trends dating back to 2004. Recalls rose 35% to their highest level since the third quarter of 2014, the report says. And recalled units increased
Devices
A Centers for Disease Control (CDC) study shows that 25% of reports to the FDA Medical Device Report (MDR) database on problems with contact lenses involved patient behaviors that could be modified to reduce the risk of eye damage. The report says that during 2005-2015, a total of 1,
Devices
bioMérieux has submitted line-by-line technical comments to FDA requesting clarifications to the agency’s draft guidance on the form and content of a medical device unique identifier. The submission comments on language in four sections of the draft.
Drugs
FDA says that Bayer has expanded its 7/21 recall of two lots of its hemophilia A drug Kogenate FS containing active ingredient manufactured before 11/2015 to include eight additional lots. An agency notice says the recall expansion is based on a company analysis of additional lots with active
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Patient Preference Information — Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling. This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Draft Guidance on Fidaxomicin. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for fidaxomicin tablets. To download this guidance, click here. To view this notice, click here.
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the FDA commissioner determines that an investigator is ineligible to receive a new animal
FDA Policy/General
Federal Register Proposed rule: FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products
FDA Policy/General
Federal Register Proposed rule/direct final rule: FDA proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability
Devices
SRS Medical Systems has gained IDE approval to enroll patients in a study to expand the indications for use for its Spanner Temporary Prostatic Stent. The stent is an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients, according to the company. Currently, it is approved for
Drugs
A DC federal court has agreed with an FDA interpretation that the statutory three-year clinical investigation exclusivities prohibits approval of second-in-time applications for a drug with the same active moiety as the drug with the exclusivity. Attorney Nicole Stakleff (Pepper Hamilton) writes in her firm’s online
Drugs
FDA has granted TG Therapeutics an orphan drug designation for its next generation PI3K Delta inhibitor, TGR-1202, for treating patients with chronic lymphocytic leukemia (CLL). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 trial for patients with both frontline and previously treated CLL. The delta
Devices
FDA has cleared a Bio2 Medical 510(k) for the Angel Catheter, intended for use in preventing pulmonary embolism (PE) in patients who cannot take anticoagulation therapy. The device provides an alternative to inferior vena cava (IVC) filters for PE protection, according to the company, and it is designed for
FDA Policy/General
FDA 8/23 announced a “direct final rule” intended to ensure that antimicrobial drugs used in animal feed remain available for therapeutic purposes in food-producing minor species after manufacturers have removed production (“growth promotion” or “feed efficiency”) claims from their labeling, as all have agreed to do. The announcement
Drugs
Galapagos and Gilead have begun a Phase 3 clinical trial program called FINCH that will investigate the efficacy and safety of 100 mg and 200 mg filgotinib once daily in rheumatoid arthritis patients. The program includes the following three studies: * FINCH 1 is a 52-week, randomized, placebo- and adalimumab-
Drugs
FDA inspections at Unimark Remedies’ active pharmaceutical ingredient Vapi facility (5/18-5/22/15) and Belva facility (8/3-8/14/15), both in India, found significant deviations from current good manufacturing practice regulations, according to an 8/15 Warning Letter. Specific violations found at the Vapi facility included: