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HTMLFDA Puts out Guidance to Require Submissions in ICH’s Electronic Format for Certain Pharmaceutical Product Applications Within Two Years
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The regulator issued guidance in accordance with the FDCA that outlines Electronic Common Technical Document (eCTD) specification requirements for submissions of new drug or biological products, requiring that all submissions be done electronically and in the ICH-developed format within the next...

 

HTMLFDA Makes More Electronic Submissions Mandatory
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 1, 2015, previously published on May 22, 2015
UPDATE: On May 27, 2015, FDA announced that it was granting additional time for companies to begin submitting electronic postmarketing safety reports for drugs and biologics. Although the effective date for the requirement is June 10, 2015, the Agency is delaying the compliance date until September...

 

HTMLFDA Makes More Electronic Submissions Mandatory
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
May 26, 2015, previously published on May 22, 2015
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and expeditious flow of information about drugs and medical devices from industry...

 

HTMLFDA Rejects Otsuka’s Assertions of Orphan Exclusivity for Abilify, Allowing Generics to Proceed
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
May 15, 2015, previously published on April 2015
The impact of the FDA’s decision is that several companies will be allowed to enter the market with generic aripiprazole, although the generics must carve out the use of the drug for treating pediatric Tourette’s Disorder from their labeling and marketing while the exclusivity period...

 

HTMLFDA Warns Nanobiotech Pharma for Using Metatags and Social Media to Make Improper Claims about Its Products
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator sent a warning letter to the life science company for using metatags to supplement the improper promotion of its products as drugs, as well as making unapproved claims on Facebook, LinkedIn and its website.

 

HTMLOPDP Sends Warning Letter to UCLA for Promoting Investigational New Drug on Taumark Website
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator warned UCLA, a partner in TauMark and the sponsor of the investigational new drug FDDNP, that it is violating the FD&C Act by promoting the brain diagnostic drug without market authorization and by failing to include adequate directions for use.

 

HTMLOPDP Warning Letter States That Discovery Laboratories’ Website for Surfaxin Makes Unsubstantiated Superiority Claims, Lacks Adequate Directions for Unapproved Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
Discovery Laboratories was warned by the regulator after a review of its website revealed that the company made unsupported superiority claims about Surfaxin as well as claims indicating that the RDS-prevention drug is intended for a use for which it lacks approval and for which its labeling fails...

 

HTMLFDA Approves Novartis’ Zarxio As The First Biosimilar In The U.S., Clearing The Drug For The Same Indications As Neupogen And Giving It A Placeholder Nonproprietary Name
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator granted a landmark approval to the copycat version of the already approved drug in the U.S., opening up the market to less expensive copies of biological products, while uncertainty related to a naming policy remains.

 

HTMLFDA Issues New Documents Governing Drug Compounding
Patrick C. Gallagher, Rachael G. Pontikes, Alison T. Rosenblum; Duane Morris LLP;
Legal Alert/Article
April 14, 2015, previously published on April 6, 2015
The first few months of 2015 have proven very active for the U.S. Food and Drug Administration (FDA) and its regulation of pharmaceutical compounding. On February 13, 2015, FDA announced the release of five new documents related to drug compounding and repackaging. The documents provide further...

 

HTMLCanada’s Anti-Spam Law
Bradley J. Freedman; Borden Ladner Gervais LLP;
Legal Alert/Article
April 9, 2015, previously published on March 24, 2015
Canada’s anti-spam law (commonly known as “CASL”) creates a comprehensive regime of offences, enforcement mechanisms and potentially severe penalties (including personal liability for corporate directors and officers) designed to prohibit unsolicited or misleading commercial...

 


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