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Latest Blogs

Proposed Rule Will Supplant FDA Informed Consent Guidance When Finalized

The FDA is proposing a rule, as announced in the Federal Register (FR) (here), to provide for relaxing the provisions of informed consent under specific circumstances.  The history of the change is explained in the FR notice.  The FDA notes that the Cures Act has provided it with the statutory basis to support the proposed regulation,

Official October OGD Numbers Are In, and Yes,  Another Record!

While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here)  on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2.  OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!

An Old Friend, Newly Designed, Comes Back to the OTC Asthma Market

I remember in the “old days” back in the 70’s, before most of you may have been born, Primatene Mist containing epinephrine, was a life saver as an OTC medicine for mild asthma.  Why did it disappear from pharmacy shelves?  Because it contained chlorofluorocarbons (CFCs) as a propellant.  As you know, CFCs were banned, and phased out of the market in 2011 in an effort to help protect the ozone layer under the Montreal Convention.

FDA Collection of Information FR Notice Provides Some Interesting Estimates

The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here).  The notice states that:

Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.  

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Latest News

Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman Consultants

LCS’ CEO, Fran Zipp, was interviewed by Economic Times during a meeting of the ISPE India affiliate.

Click here for the full interview.

Fran Zipp Elected Vice Chair of ISPE International Board of Directors

LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The newly elected Board includes LCS’ own CEO and President,