Drugs
Pfizer and several other stakeholders are asking FDA to provide more detail on how it will incorporate patient experience into regulatory decisions such as benefit/risk considerations. “For example,” Pfizer says in a comment letter on an agency patient-focused drug development (PFDD) discussion document, “it would be helpful to
Drugs
FDA has issued two documents relating to bioresearch monitoring. A draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions, describes the electronic submission of certain data and information in standardized formats, and supersedes a previous draft guidance.
Drugs
The DC federal court says FDA has given an adequate rationale for granting pediatric exclusivity to Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol and norgestimate) but denying it for Amgen’s Sensipar (cinacalcet hydrochloride). Amgen had sued FDA over the agency’s decision not to grant Sensipar pediatric
Drugs
A law firm that has been litigating cases against Forest Pharmaceuticals related to its off-label promotion of the antidepressant Celexa (citalopram) for use in children and adolescents says Forest lied to FDA and the U.S. Attorney’s Office and settlements with the company should be reopened. “Documents and
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on issuing and overseeing clinical holds of investigational new drug (IND) applications. The MAPP says that because the regulations specify that an IND goes into effect 30 days after it is received by FDA unless the agency imposes a clinical
Drugs
A 5/29-5/31/17 FDA inspection at Casmara Cosmetics, a Valencia, Spain, drug manufacturing company, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/12 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory
Drugs
The DC federal court has denied a Ferring Pharmaceuticals motion asking the court to enforce an earlier grant of summary judgment to Ferring that remanded to FDA the case of Ferring’s request for five-year exclusivity for its Prepopik colonoscopy preparation solution. The case revolves around a shifting determination
Drugs
FDA has approved an Osmotica Pharmaceutical NDA for Osmolex ER (amantadine extended release tablets) for treating Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms (movement disorders) are known side effects of many common medications. The drug’s labeling says it is contraindicated in patients with
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that during GDUFA 1 her Office of Research and Standards “built an extensive research portfolio to support development of new methodologies and tools to help establish equivalence standards.” In a report, Uhl says that between 2013 and 2017 OGD awarded
Drugs
AllTrials says its online clinical trial tracking tool will begin flagging clinical trials that have reached the 13-month FDA Amendments Act of 2007 (FDAAA 2007) limit without posting trial results and the fines those companies should be paying. In an open letter to FDA commissioner Scott Gottlieb, AllTrials says
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has voted 6 to 4 to not recommend approval of a Pacira Pharmaceuticals supplemental NDA for Exparel (bupivacaine liposome injectable suspension) and its use as a nerve block to produce regional analgesia. The six panel members agreed that more research data
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. This is the first treatment approved for this disease stage to
Drugs
As a means to help bring down rising drug costs, FDA commissioner Scott Gottlieb says he is stepping up pressure against brand drug makers and their tactics to block generic drug market entries. In a 2/15 interview with Kaiser Health News, the agency head expressed his frustration with brand
Drugs
FDA has published five guidances as part of a broader focus on advancing treatments for neurological disorders that are not adequately addressed by available therapies. Commissioner Scott Gottlieb says (statement includes links to guidances) the documents “provide details on how researchers can best approach drug development for certain neurological conditions
Drugs
FDA has denied a 3/19 petition submitted by Escher Fund for Autism asking it to withdraw approval of 17-alpha hydroxyprogesterone caproate (17-HPC), including Amag Pharmaceuticals’ Makena, as a drug used in pregnancy, pending assessments of potential deleterious effects on the fetal germline. The denial letter says the
Drugs
The Critical Path Institute says an FDA discussion document, appendices, and glossary for a guidance on patient-focused drug development “provides useful background information to entities like patient advocacy organizations that may have little experience with drug development and will be useful in that respect.” The institute’s comment letter
Drugs
Writing for Washington Legal Foundation, two Fried, Frank attorneys say the time may be right to look again at constitutionality of the False Claims Act’s (FCA) qui tam (relator or whistleblower) provisions that allow a whistleblower to independently prosecute a False Claims Act case on behalf of the United
Drugs
FDA has accepted for review an Agios Pharmaceuticals NDA for ivosidenib (AG-120) for treating patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation. The submission was granted a priority review, with a user fee review action date of 8/21. Ivosidenib is a first-
Drugs
Apace Packaging has recalled one lot of shingles therapy acyclovir tablets, USP, 400mg, (NDC# 50268-061-15, lot number 19900) due to a product mix-up. A small number of blister cards containing acyclovir tablets, 400mg, may potentially also include torsemide, 20mg, tablets. “Missing a dose of acyclovir tablets could
Drugs
FDA says its 2/7 approval of an ANDA for trientine hydrochloride (Valeant’s Syprine) to treat Wilson disease renders moot an 8/17/17 petition requesting such an approval. The agency response says the petition “asserted that the approval of an ANDA for trientine hydrochloride will make available a
Drugs
Pharmaceutical industry stakeholders are telling FDA about many regulations they believe could be eliminated or modified in the interest of reducing administrative burden and improving efficiency. In a 127-page response, Pharmaceutical Research and Manufacturers of America lists 41 topics under three overriding categories — manufacturer communications and prescription drug labeling,
Drugs
FDA has issued a guidance, Regulatory Classification of Pharmaceutical Co-Crystals, to give applicants planning to submit NDAs and ANDAs information on the appropriate regulatory classification of pharmaceutical co-crystal forms. The guidance includes information about the data that applicants should submit to support the appropriate classification of a co-