Drugs
FDA says it has redesigned its drug shortage Web page to make it easy to use to quickly locate current drug shortages and other important information. “The new look and organization of content direct users to current information quickly while still providing access to important records and historical data,” an
Drugs
FDA has issued a draft guidance, Major Depressive Disorder: Developing Drugs for Treatment, to aid sponsors in clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder. “Specifically,” the document says, “this guidance addresses FDA’s current thinking regarding the overall development program and clinical
Drugs
Several stakeholders are raising issues related to an FDA docket on quality considerations for metered dose inhaler and dry powder inhaler products. The Association for Accessible Medicines, representing generic drug interests, voices three key concerns: industry should be granted a transition period to comply with the new requirements; the agency
Drugs
Yale University researchers who looked at 92 expanded drug access programs registered at ClinicalTrials.gov over the last two decades say that the balance established by FDA and the drug industry between investigational new drug access and protection of patients from therapies without established safety could be compromised by policy
Drugs
FDA commissioner Scott Gottlieb says the agency wants to build on success it has had in promoting robust generic drug entry with two new initiatives that are part of the 2019 budget request. Writing in an FDA Voice blog post, Gottlieb says the first initiative will create a Knowledge-aided
Drugs
A 9/18-9/22/17 FDA inspection at Biologique Recherche, Suresnes, France, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 6/8 Warning Letter. Specific violations noted in the letter were: * failing to have, for each batch of drug product, appropriate
Drugs
A New Jersey federal court has approved Indivior’s request for a temporary restraining order to stop Dr. Reddy’s Laboratories from launching its generic form of Indivior’s Suboxone (buprenorphene and Naloxone sublingual film) opioid disorder medication. Media accounts indicate that the order will remain in place until a
Drugs
A bipartisan group of 31 senators has written to FDA commissioner Scott Gottlieb asking that the agency’s Drug Shortage Task Force “work with stakeholders and federal agencies to determine the root causes of drug shortages and develop recommendations to ensure that appropriate supplies of essential medicines are always available.
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton says IV fluid shortages that have existed since 2014 and were exacerbated by Hurricane Maria’s effect on Puerto Rican drug manufacturers in 2017 are finally easing. An agency news release says that “after much work and a great deal of collaboration
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports continued development of targeted therapies for molecularly defined conditions, it is important to avoid unintended consequences that might adversely affect orphan drug development. “If the incentives for development of products shift away from tumor histology to tissue agnostic
Drugs
FDA has lifted a clinical hold against Solid Biosciences’ Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treating Duchenne muscular dystrophy. In its letter, the agency acknowledged that the company satisfactorily addressed all clinical hold questions. Solid Biosciences has begun activities to resume the
Drugs
FDA has issued a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and requested additional information to support the IND. The clinical trial is intended to evaluate CAR T cells manufactured with “Sleeping Beauty” technology as an
Drugs
University of Ottawa law professor Amir Attaran has suggested that the Canadian government should look at suspending U.S. drug patents as the Trump Administration turns up the heat on its trade dispute with Canada. The U.S. holds more pharmaceutical patents and other intellectual property licenses than any other
Drugs
Federal Register notice: FDA is announcing an opportunity for public comment on an information collection extension for the agency guidance entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (OMB Control Number 0910–0802). To view the notice, click here.
Drugs
FDA has issued Ortho Dermatologics a complete response letter on its NDA for Duobrii (halobetasol propionate and tazarotene) lotion and its use in treating plaque psoriasis. The letter did not cite any deficiencies related to the product’s clinical efficacy or safety, and only noted questions regarding pharmacokinetic data, according
Drugs
FDA has made available a guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to treating EB, including FDA’s current thinking on endpoint considerations. It notes that there is “not yet sufficient clinical trial precedent
Drugs
FDA has posted an ICH guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers.” The document is intended to address challenges sponsors have experienced when implementing recommendations on nonclinical evaluation for anticancer pharmaceuticals. It also encourages reducing, refining and replacing the use of animals in clinical trials.
Drugs
Public Citizen says the Senate Judiciary Committee “threw a punch for affordable prescriptions” 6/14 by voting to advance the CREATES Act that would prevent branded drug manufacturers from abusing regulatory rules to deny generic and biosimilar manufacturers access to product samples. “Corporations have long used this practice to delay
Drugs
FDA has published a draft guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, to give sponsors clinical and non-clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products regulated within CDER for preventing sexually acquired HIV-
Drugs
FDA says the manufacturers and labelers of 11 drug products that contain isometheptene agreed to comply with a 10/12/17 agency order to stop distributing their isometheptene mucate-containing drug products as of 1/1/18. An agency notice says the affected products contain either isometheptene mucate, discloralphenazone, and
Biologics
CBER says that as of 10/1, it will increase the use of secure e-mail for regulatory communications in an effort to streamline and facilitate communication with sponsors and protect proprietary and company confidential information. After 10/1, the notice says, outgoing e-mail communications containing regulatory information will
Drugs
FDA has issued scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overload in patients with heart failure. The letter indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study, according to the