Drugs
Pfizer’s Hospira drug unit appears to be getting deeper into FDA hot water involving intractable GMP issues at the firm’s McPherson, KS sterile drug manufacturing site. The latest indication is a just-released Form FDA-483 that lists numerous repeat observations cited after an August follow-up inspection
Drugs
Pfenex has submitted an NDA for PF708, indicated for treating osteoporosis. The 505(b)(2) NDA submission, which references Eli Lilly’s Forteo (teriparatide), is based on positive data from the PF708-301 Phase 3 clinical study that showed comparable overall profiles between PF708 and Forteo after 24 weeks of
Drugs
FDA has cleared a Pear Therapeutics 510(k) for its mobile medical application called reSET-O to help increase retention in an outpatient treatment program for individuals with opioid use disorder (OUD). The app is a prescription cognitive behavioral therapy intended to be used in addition to outpatient treatment under
Drugs
FDA has issued a safety communication reporting on preliminary findings and providing important information to hospitals and health care providers who use and reprocess duodenoscopes. Interim results from studies ordered by the agency show “higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing
Drugs
CDER deputy Center director for clinical science Bob Temple is being appointed to a new position at the Center — Office of New Drugs senior advisor. Temple has for many years worn simultaneous hats within CDER and his new role is being added to his deputy Center director responsibilities; he, however,
Drugs
AbbVie has stopped enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). The halt in enrollment is based on a recommendation from an independent data monitoring committee that found a shorter overall survival
Drugs
CDER director Janet Woodcock has announced that Office of New Drugs (OND) deputy director Peter Stein has been selected as permanent director of the Office. Stein replaces John Jenkins, who retired two years ago. In Jenkins' absence, Woodcock assumed the role of OND director until a replacement was named.
Drugs
India’s Lupin Pharmaceuticals says FDA 11/26-12/4 inspections at the firm’s Mandideep location found “largely procedural” observations. Mandideep houses the company’s cardiovascular “Pril” active pharmaceutical ingredient (API) facilities, cephalosprorin API facilities, and cephalosporin solid oral dosage form facility. The company says the “Pril” API facilities
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) for combination use with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy) for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Approval is based on data from the Phase
Drugs
FDA says health care professionals and patients should not to use drug products intended to be sterile that were produced in an “inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, FL, due to lack of sterility assurance.” During a recent inspection of Promise Pharmacy’s facility, agency
Drugs
FDA has released a 2019 strategic framework under which it will continue to advance opportunities to use real-world data to improve regulatory decisions. FDA commissioner Scott Gottlieb says the strategic framework “is aimed at leveraging information gathered from patients and the medical community to inform and shape FDA’s
Drugs
FDA has issued a draft guidance, In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products, to describe considerations for development and labeling of companion diagnostic devices to support the indicated use of multiple drug or biologic oncology products when appropriate. The document includes factors
Drugs
FDA says Mylan is expanding its consumer-level nationwide recall to all lots of valsartan-containing products within expiry. The agency notice says the 104 additional lots include 26 lots of amlodipine and valsartan tablets in various strengths, 51 lots of valsartan tablets in various strengths, and 27 lots of
Drugs
Tris Pharma has recalled three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concentrations of ibuprofen than labeled. There is a remote possibility that infants, who may be more susceptible to higher drug potency levels, may be
Drugs
FDA says it has established a docket to obtain data, information, and comments to aid it in assessing the safety and effectiveness of food handler antiseptic drug products (antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. A Federal Register announcement
Drugs
FDA has released the FDA-483 issued following a 10/8-10/16 inspection at Gadea Biopharma, a Leon, Spain, contract sterile injectable drug products manufacturer. The six inspection observations are: * information stated in the submitted drug application is not exactly as is on site; * labeling equipment is not qualified
Drugs
Pharmaceutical Research and Manufacturers of America says it “commends FDA on the improvements that have been made” in the agency’s draft guidance on adaptive designs for clinical trials of drugs and biologics over the 2010 guidance. Its comment letter says the current draft “provides clear recommendations for complex design
Drugs
FDA has accepted a Genentech sBLA for its Tecentriq (atezolizumab) and will give it priority review for a new indication for initial treatment, in combination with carboplatin and etoposide, of people with extensive-stage small cell lung cancer. The agency is expected to make a decision by 3/18/19.
FDA Policy/General
The Department of Justice says that after a year-long review of the “individual accountability policy” enunciated by then-deputy attorney general Sally Yates in a 2015 memo, it is reforming the policy to provide more potential for companies to earn cooperation credit and to resolve cases more quickly. Attorney
Drugs
The Federal Trade Commission (FTC) has approved 5-0 a statement commenting on an FDA draft guidance that aims to deter drug companies from abusing the citizen petition process to delay approval of and competition from generic drugs. The comment says that while some citizen petitions raise genuine issues for
Drugs
A 5/17-5/18 FDA inspection at Barox Co., Ltd., Seongnam, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/28 Warning Letter says the specific violations were: * failing to establish written responsibilities and procedures applicable to the quality control unit; * failing
Drugs
An online FDA drug science research report says the agency is evaluating an approach to use mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and other diseases. The document says that recent development of a multi-attribute method (MAM) has allowed mass spectrometry to be