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 A draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions, describes the electronic submission of certain data and information in standardized formats, and supersedes a previous draft guidance.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
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Collegium Pharmaceutical exhibit booth for its Xtampza ER (oxycodone) extended-release capsules for oral use made false or misleading representations because it failed to adequately communicate information about the serious risks associated with the drug’s use. A 2/9
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
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Casmara Cosmetics, S.A. Valencia, Spain (2/12): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have,
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
Devices
A 2/20-2/22/17 FDA inspection at Pacific Hospital Supply, Miaoli, Taiwan, found Quality System Regulation violations in the firm’s manufacturing of disposable medical supplies including catheters, cannulae, tubing, and aspirators. A just-released 5/26/17 Warning Letter says violations noted on an FDA-483 were:
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
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Genmab’s Darzalex (daratumumab) is 1,939 days. Of this time, 1,808 days occurred during the testing phase and 131 days during the approval phase. Darzalex is indicated for treating patients with multiple
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Eli Lilly’s Portrazza (necitumumab) is 2,533 days. Of this time, 2,175 days occurred during the testing phase and 358 days during the approval phase. Portrazza is indicated, in combination with gemcitabine
FDA Policy/General
Federal Register notice: FDA has announced that its Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, and Office of Regulatory Science have been restructured 6/2016 under its Program Alignment Initiative. The reorganization centralized and streamlined laboratory operations, scientific research, and support functions into the Office of
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Export of Food and Drug Administration-Regulated Products: Export Certificate” (OMB Control Number 0910-0498. To view the notice, click here.
Devices
FDA will publish 2/21 an amendment to its regulations on accepting data from clinical investigations for medical devices. The agency says the change will require that data submitted from clinical investigations held outside the U.S. intended to support an IDE, 510(k), request for de novo classification, PMA,
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
FDA Policy/General
Public Meeting on Pediatric Device Development Federal Register notice: FDA announces an 8/13-14 public meeting entitled “Pediatric Medical Device Development.” 02/16/2018 Guide on How to Prepare Combination Product Designation Request Federal Register notice: FDA makes available a guidance entitled “How to Prepare a Pre-Request for
FDA Policy/General
St. Jude Children's Research Hospital has agreed to spend $412 million to develop an advanced research center as part of a $1 billion capital expansion at its St. Jude campus. The center is intended to foster an environment where scientists and clinicians will pursue breakthroughs in hopes of
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
FDA Policy/General
Federal Register notice: FDA has announced an 8/13-14 public meeting entitled “Pediatric Medical Device Development” to identify strategies to improve the medical device ecosystem to enhance development and innovation of pediatric devices. Topics for discussion will include ways to improve research infrastructure and research networks to improve the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD)” that explains the Office of Combination Product’s Pre-RFD process the type of information needed to obtain a preliminary assessment from the agency. The Pre-RFD process is available