Drugs
Former FDA commissioner Scott Gottlieb has returned to the venture capital firm he was at just before being appointed to the agency’s top post in 2017 — New Enterprise Associates (NEA). Previously at NEA for 10 years as a venture partner, Gottlieb returns as a full-time investing partner on
Drugs
The Lower Health Care Costs Act of 2019, bipartisan legislation released for comment by the Senate HELP Committee, includes more than 30 specific provisions, including some affecting FDA, to reduce the costs Americans pay for health care. Last year, the committee asked the American Enterprise Institute, Brookings Institution, governors, state
Drugs
FDA has released the FDA-483 issued following a 5/6-5/15 inspection at Lupin, Ltd., Aurangabad, Maharashtra, India. The form’s inspection observations for the manufacturer of finished drugs were: 1. written records of investigations into unexplained discrepancies and the failure of a batch or any of its
Drugs
AstraZeneca says an FDA draft guidance on bioavailability (BA) studies submitted in NDAs and INDs mentions bioequivalence several places in the document. The company’s comment letter says “if demonstration of bioequivalence is not a requirement, we suggest replacing ‘BE studies’ with ‘BA studies’ in this guidance. It is appreciated
Drugs
The Justice Department has filed a complaint in a New York federal court seeking a permanent injunction against Confidence USA, Port Washington, NY, and its president and manager, to prevent them from marketing dietary supplements without following current good manufacturing practices. A department news release says FDA inspections repeatedly showed
Drugs
The Office of Management and Budget Spring 2019 Rule List includes 80 proposed and final stage rules from FDA. The HHS listing includes 61 regulations in the proposed rule stage for FDA-regulated products, and 19 at the final rule stage.
Drugs
FDA has accepted for review an Agile Therapeutics NDA resubmission for Twirla (ethinyl estradiol and levonorgestrel transdermal system), an investigational low-dose combined hormonal contraceptive patch. The original NDA received a complete response letter 12/2017 that, according to the company, identified deficiencies relating to (1) quality control adhesion test
Drugs
FDA Office of the Commissioner chief of staff Lauren Silvis says the agency is making progress on several consumer health activities. In 5/21 remarks to the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, Silvis discussed agency activities on OTC monograph reform, the Nonprescription Safe Use Regulatory Expansion
Drugs
FDA has approved an EpiBone IND to allow a Phase 1/2 clinical trial of its lead bone product, EpiBone-Craniomaxillofacial (EB-CMF), that is being evaluated as a potential treatment for ramus continuity defects in the mandible. The ramus is a key component of the jaw bone which attaches
Drugs
A Texas federal judge has signed and entered a permanent injunction ordering Pharm D Solutions, a Texas drug compounder, and its owners, to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. An FDA news release
Drugs
FDA has approved a Mayne Pharma supplemental NDA for Sorilux (calcipotriene) Foam, 0.005% to expand its use in adolescents (aged 12 years and older) with plaque psoriasis of the scalp and body. Previously, the product was indicated for patients aged 18 years and older. The original approval in 2010
Drugs
A 10/22-10/26/18 FDA inspection at Centurion Laboratories Private Limited, Manjusar, Gujarat, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A just-released 4/5 Warning Letter says the specific violations were: * failing to ensure that laboratory records include complete data derived
Drugs
Two staffers in the CDER Office of Surveillance and Epidemiology say they are aware of instances in which prescription drug litigation has had significant impacts on signals of disproportionate reporting (SDRs) to the FDA Adverse Event Reporting System (FAERS). Writing online in the journal Drug Safety, the two identified litigation-
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that increasing patients’ awareness of and access to clinical trials are critical factors in making drug development innovation possible. Responding to an FDA 3/18 workshop on enhancing the incorporation of patient perspectives on clinical trials, the industry group says
Drugs
A white paper, “Designing the Future of Cell Therapies,” produced by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy, says there is great interest in exploring new treatment modalities to encompass treatment of solid tumors, which comprise 90% of all cancers and the majority of cancer deaths.
Biologics
FDA has released a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The document describes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to
Drugs
Former FDA commissioner Scott Gottlieb says the nation’s healthcare system needs to rethink how drugs and other therapies are paid for. “The drug debate is often focused on price,” he writes in a CNBC commentary. “But the real imperative turns on questions of access. Drugmakers have a compact with
Drugs
An FDA inspection last month of Cadila Healthcare’s Gujarat, India manufacturing facility has led to a 23-page Form 483 that cites significant GMP violations. For example, the agency said the firm’s equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination. The inspection
Drugs
The U.S. Supreme Court has unanimously ruled that FDA preemption questions are for a judge to decide, not a jury. In a 5/20 opinion in a Merck product liability lawsuit involving osteoporosis drug Fosamax, the high court reiterated that “clear evidence that the FDA would not have approved
Drugs
FDA has approved an Akorn ANDA for a generic copy of Meda Pharmaceuticals’ Astelin (azelastine hydrochloride) nasal spray, 0.1%, indicated for treating symptoms of seasonal allergic rhinitis in adults and pediatric patients aged five years and older, and for treating symptoms of vasomotor rhinitis in adults and adolescent patients
Drugs
FDA has approved an Akorn ANDA for a generic copy of Meda Pharmaceuticals’ Astelin (azelastine hydrochloride) nasal spray, 0.1%, indicated for treating symptoms of seasonal allergic rhinitis in adults and pediatric patients aged five years and older, and for treating symptoms of vasomotor rhinitis in adults and adolescent patients
Drugs
AbbVie has stopped a Phase 3 study called INTELLANCE-1 that was evaluating depatuxizumab mafodotin in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, based on data that demonstrated no survival benefit for treated patients. An interim analysis by the company’s independent